As part of an academic medical center, the Department of Surgery at Northwestern University Feinberg School of Medicine (Feinberg) aims to improve the human health through scientific research.
About Clinical Trials
Clinical trials test or study drugs, surgical procedures, medical devices, or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.
Department of Surgery Clinical Trials
The following searchable list includes all Department of Surgery clinical trials currently looking for participants.
Please feel free to contact us with inquiries about any of our ongoing research.
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appe…
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: - Limited Early Stage (Stage 1): up to 175 subjects at up to 15 sites - Pivotal Stage (Stage 2): up to 600 subjects at up to 50 sites All patients from both stages will be included in the primary analysis.
A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with an Acute, Complicated Type B Aortic Dissection
This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissect…
This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissection. One way to repair an acute, complicated type B aortic dissection is with an endovascular stent-graft. A stent-graft is a polyester fabric tube (graft) sewn onto metal springs (stent). The stent-graft is compressed inside a narrow plastic tube called a delivery system, which is inserted into the blood vessels in the groin area (femoral/iliac artery) and then threaded through the blood vessels to be placed at the area of the dissection inside the aorta. This research study will assess and evaluate safety and performance of an endovascular stent graft called the RelayPro Thoracic Stent-Graft System (the “Study Device”). The Study Device is investigational, which means it is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States. We expect that participants will be in this research study for approximately 5 years after their endovascular repair procedure. Participants will return to clinic at 1-month, 6-months, and 1-year, and then annually out to 5 years. These visits are considered part of standard care, and the results of test done at these visits will be recorded for the study. We expect up to 5 people here will be in this research study out of 80 people in the entire study nationally.
Subject must have an acute (symptom onset to diagnosis within 2 weeks)or subacute, complicated type B aortic dissection (entire dissection is distal to the left subclavian artery (LSA)), confirmed by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis ≤ 6 weeks, with at least one of the following:
- Malperfusion of the viscera, kidneys, spinal cord, or lower extremities, measured by clinical or radiographic evidence;
- Intractable pain.
Proximal and distal aortic neck with diameter between 19 mm and 42 mm.
Subject's anatomy must meet all of the following anatomical criteria:
a. Proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery.
i. Dissection is permitted in the distal attachment zone but is not permitted in the proximal attachment zone.
b. The length of the attachment zones will depend on the intended stent-graft diameter and type of graft selected.
c. The proximal attachment zone should be: i. 15 mm for 22 - 28 mm RelayPro grafts with bare stent (20 mm for RelayPro grafts with non-bare stent). ii. 20 mm for 30 - 46 mm RelayPro grafts with bare stent (25 mm for RelayPro grafts with non-bare stent). iii. Proximal to non-dissected segment (healthy zone). d. The distal attachment zone should be 20 mm for all RelayPro grafts. e. Coverage of the left subclavian artery is permitted with mandatory revascularization if patent left internal mammary artery (LIMA) bypass or left upper extremity (LUE) arteriovenous graft or anomalous vertebral artery off the aorta. Revascularization must be performed prior to device placement, and may occur during implant procedure, provided it is before coverage of the LSA by the endograft.
5. Proximal attachment zone containing a straight segment (non-tapered, non-reverse-tapered, defined by <10% diameter change) with lengths equal to or greater than the required attachment length for the intended device.
6. Vascular dimensions (e.g., aortic diameters, length from left subclavian to celiac artery) must be in the range that can be safely treated with the RelayPro Thoracic Stent-Grafts.
7. Adequate iliac or femoral artery access for introduction of the RelayPro Delivery System. Alternative methods to gain proper access may be utilized (e.g., iliac conduit).
8. Subject willing to comply with the follow-up evaluation schedule. 9. Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment.
Subjects will be excluded from the study if any of the following apply:
Diagnosis of traumatic injury or transection of the descending thoracic aorta.
Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device.
Planned coverage of left carotid or celiac arteries; or anatomic variants that would compromise circulation to the carotid, vertebral, or innominate arteries after device placement, which is not amenable to subclavian revascularization.
Prior endovascular or surgical repair in the descending thoracic aorta. The device may not be placed within any prior endovascular or surgical graft.
Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta, requiring repair. Dissection extension into the abdominal aorta is acceptable.
Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure.
Major surgical or medical procedure within 30 days prior to the planned procedure, or is scheduled for a major surgical or medical procedure within 30 days post implantation. This excludes any planned procedures for the prospective stent-graft placement.
Untreatable allergy or sensitivity to contrast media or device components, including metal stents.
Known or suspected connective tissue disorder.
Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or post-repair.
Coronary artery disease with unstable angina.
Severe congestive heart failure (New York Heart Association functional class IV).
Stroke and/or Myocardial Infarction (MI) within 3 months of the planned treatment date.
Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy outside the hospital setting.
Acute renal failure or chronic renal insufficiency, and not receiving dialysis.
Active systemic infection and/or mycotic aneurysms.
Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements.
ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation).
Less than two-year life expectancy.
Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation.
Currently pregnant or planning to become pregnant during the course of the study.
Medical, social, or psychological issues that Investigator believes may interfere with treatment or follow-up.
A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart …
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. If you agree to participate in this study, the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) and delivery system will be used to replace your failing bioprosthetic aortic valve. The delivery systems are the Commander system (transfemoral access – through the leg) and the Certitude system (transapical and transaortic access through the heart, when a small incision is made in your chest). The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) or any other governmental agency in North America for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. If you agree to participate in this research study and pass the screening tests, your involvement will last approximately 10 years. You will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.
NYHA Functional Class ≥ II.
Heart Team agrees valve implantation will likely benefit the patient.
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
Severe regurgitation (>3+) or stenosis of any other valve.
Failing valve has paravalvular regurgitation (includes those instances that have been previously treated with a plug due to paravalvular regurgitation).
Failing valve is unstable, rocking, or not structurally intact.
Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
Increased risk of embolization of THV (e.g., surgical valve that is non-stented and non-calcified).
Known bioprosthetic valve with residual mean gradient >20 mmHg at the end of the index procedure for implantation of the original valve.
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for pa…
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. The Study Device is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. The Study Device and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV. The SAPIEN 3 THV that is being investigated for this study has been implanted in over 3,000 patients with symptoms of severe aortic stenosis and has been approved by FDA for those patients. Participation in the study will vary, depending upon the treatment group you are assigned. If you are in the TAVR group, your participation will be for 5 years. If you are in the Clinical Surveillance group, your participation could range from 5 to 10 years. If you are in the registry group, your participation will be for 5 years. We expect up to 166 people will participate in the main study and up to up to 150 in the registry here at Northwestern. A total of 1109 patients will participate in the main study and up to 1000 patients will participate in the registry internationally.
Severe aortic stenosis
Patient is asymptomatic
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.
Patient is symptomatic.
Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
Aortic valve is a unicuspid, bicuspid, or is non-calcified.
Severe aortic regurgitation (>3+).
Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide The C.L.O.T. Investigation System
The purpose of this research study is to find out if PerClot is safe and effective as a part of surgery to stop bleeding. Pe…
The purpose of this research study is to find out if PerClot is safe and effective as a part of surgery to stop bleeding. PerClot is a device in granule form made from the starch of a potato. The starch has been engineered in a way that the powder absorbs water and helps to form a clot. This kind of device (topical hemostat) is intended for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular, and arteriolar bleeding by pressure, ligature, or other conventional procedures is ineffective or impractical. PerClot is left in your body after surgery. In animal studies, it has been found that PerClot is absorbed by the body in a few days after surgery. This has not been demonstrated in humans and can vary depending on the amount of device applied. This can also depend where it is applied. This research study will collect follow-up data after PerClot is used. PerClot is an investigational device in the United States. This means it has not been approved by the Food and Drug Administration (FDA). PerClot has been an approved medical device in Europe since 2008. This research study plans to enroll approximately 324 study participants at approximately 25 U.S. sites, including approximately 10 people from this institution. We expect that participants will be in this research study for approximately 6 weeks; however, if you currently have, or are diagnosed with cancer during the study, you will be contacted by the study coordinator on the telephone at 24 months after your surgery to ask questions about your general health. Research Trial Contact Information: For more information, participants and clinicians may contact the research team at (312) 926-4000 or firstname.lastname@example.org.
Undergoing an open elective cardiac surgical procedure (Epicardium, Aortic Anastomosis, or Aortotomy Suture Line)
Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A prospective, multicenter, randomized, controlled pivotal trial to assess transcatheter mitral valve repair with Edwards Cardioband System and guideline directed medical therapy (GDMT) compared to GDMT alone in patients with functional mitral regurgitation (FMR) and heart failure.
This study is enrolling patients with moderate-to-severe or severe functional mitral regurgitation (FMR). FMR occurs when the two leaflets of the mitral valve do not close properly, causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. This can lead to shortness of breath and make the heart weaker because it cannot pump enough blood for the body’s needs. The purpose of this study is to evaluate a new device to treat patients who might benefit from repair of their mitral heart valve due to functional mitral regurgitation. The device is called the Edwards Cardioband System (“Edwards Cardioband System”). The device is investigational, which means it is not yet approved by the U.S. FDA for sale in the United States. This device is placed without the need for an open-heart procedure and without the need for a heart and lung machine. Instead, the device is delivered using a less invasive approach where the Cardioband System is inserted through a vein in the groin and threaded to the heart using a delivery catheter (small plastic tube). For this study patients will be “randomized” or assigned by chance to one of two study groups: Device group or the Control group. Patients will be randomized 2:1, which means each patient has a 2 to 1 chance of being assigned to the Device group (twice as likely to be in the Device group as the Control group). Subjects assigned to the Control Group may be eligible to receive the Study Device after their 1 year study visit. Participation in this study will last for approximately 5 years. Both Device and Control Group participants will be asked to return for visits at 1 month, 6 months, and 1, 2, 3, 4 and 5 years. This study is being conducted in up to fifty (50) hospitals in the United States, Canada, and/or Europe and plans to enroll up to 525 participants, including approximately 10 people from this institution
Inclusion: 1. Functional MR (≥ 3+ by echo); 2. Patient hospitalized due to heart failure during 12 months prior to enrollment OR BNP >400 pg/ml or NT‐BNP>1500 pg/ml; 3. LVEF > 20% and LVEDD ≤ 70mm 4. NYHA Class II‐IVa heart failure symptoms despite medical therapy Exclusion: 1. Degenerative MR including mixed degenerative/functional MR; 2. Severe mitral annular calcification; 3. Hypertrophic cardiomyopathy; 4. Severe tricuspid regurgitation;
APOLLO Trial Clinical Investigation Plan - Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation
This study is enrolling subjects with severe symptomatic mitral regurgitation to test a new investigational device for …
This study is enrolling subjects with severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. The new investigational device is a mitral valve replacement called the IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of the TMVR device is to function similarly to a standard bioprosthetic (man-made) valve implant in that it allows blood to flow only in the forward direction, relieving mitral regurgitation. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open, the patient is put on heart-lung bypass support and the heart is temporarily stopped to sew in the valve. The TMVR device is intended to be placed through a less invasive procedure, without sewing, and without requiring heart-lung bypass support or stopping the heart.
INCLUSION: 1) Subject has severe symptomatic mitral regurgitation as defined by the ASE. 2) Patient is a candidate for bioprosthetic mitral valve replacement EXCLUSION: 1) Prior mitral valve surgery including previously implanted mitral valve, ring, or band. 2) Heart Team agrees predicted risk of operative mortality is <3% at 30 days or has ≥35% risk of mortality or irreversible major morbidity at 30 days. 3) mitral anatomy that would preclude management of the sub-valvular apparatus and/or full chordal sparing
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 to Treat Chronic Non-healing Foot Ulcers in Diabetic Patients with Concomitant Peripheral Arterial Disease (PAD)
This study is enrolling subjects who have type I or II diabetes with…
This study is enrolling subjects who have type I or II diabetes with current treatment control, peripheral arterial disease [narrowing of blood vessels that reduce the blood flow to your limbs], and a chronic, nonhealing ulcer on one foot. Ulcers initially occur due to trauma, pressure loading [force applied to the skin], and / or neuropathy [problems with the nerves in your feet]. Ulcers don’t heal because of infection and / or when diabetes and poor circulation interfere with normal healing. Researchers have discovered that a protein called hepatocyte growth factor (HGF) that your body naturally produces in small amounts may cause the growth of new blood vessels, protect nerves, and stimulate wound healing. Unfortunately, your body only makes a small amount of this protein and not always in the areas where you need it. Researchers have found a way to increase the amount of HGF in your leg. They have isolated the genes responsible for directing the production of HGF, and have designed a product that can be injected into your leg. In the research study, the HGF gene or placebo will be injected into your calf muscle cells to evaluate if it helps ulcer healing. The product being used in this study is called VM202. VM202 is an experimental drug that is not yet approved by regulatory authorities (the US Food and Drug Administration [FDA]). VM202 is a plasmid (a small piece of DNA), which includes the HGF genes. This study is intended to help determine the safety and efficacy of VM202 in subjects with a chronic, nonhealing ulcer. VM202 or placebo will be injected into your calf muscles in one leg (the leg with the ulcer on your foot), using a syringe with a fine needle.
Diabetic foot ulcer with peripheral artery disease subjects
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening i…
This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2. A tear in your aortic wall (dissection). Blood flows through this tear, causing the layers of the aortic wall to separate (dissect) and create a new channel for blood flow. This channel may continue to grow and could rupture. 3. Bleeding and blood clots within your aortic wall (intramural hematoma). This can lead to weakening of the aortic wall and aortic rupture. 4. A lesion (wound) or ulcer in your aortic wall caused by aortic disease and can progress and lead to an aortic aneurysm, dissection, or rupture. 5. A traumatic injury to your aorta that can result in a tear, lesion, or rupture of the aortic wall. The aorta is the main artery in the human body that carries oxygenated blood to all parts of the body. Disease of or injury to the aorta can be a life threatening condition The study will look at treating these aortic diseases and injuries with a new medical device called the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device). Depending on the location of your aortic disease or injury, the study device will be implanted inside your aorta and one of the main arteries that branches off your aorta supply blood to the brain and arms. Study participants will be expected to return for follow-up visits with the Study Doctor at one (1), six (6), 12, 24, 36, 48, and 60 months following the procedure. This research study plans to enroll up to 435 study participants at approximately 40 sites across the country, including up to 5 people from this institution.
Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
Age ≥18 years at time of informed consent signature
Subject is capable of complying with protocol requirements, including follow-up
Informed Consent Form (ICF) is signed by Subject or legal representative
Must have appropriate proximal aortic landing zone.
Must have appropriate target branch vessel landing zone
For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.
Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
Previous endovascular repair of the ascending aorta
Previous endovascular repair of the DTA with a non-Gore device
Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access
Life expectancy <2 years
Myocardial infarction within 6 weeks prior to treatment
Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
Patient has a systemic infection and may be at increased risk of endovascular graft infection
Pregnant female at time of informed consent signature
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
Participation in another drug or medical device study within one year of study enrollment
Known history of drug abuse within one year of treatment
Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
Planned coverage of celiac artery
Patient has known sensitivities or allergies to the device materials
Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
Persistent refractory shock (systolic blood pressure <90 mm Hg)
Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis
A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determ…
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
A Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Patients With Kidney Transplant
To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated rejection (of renal allograft) (AMR) in kidney transplant recipie…
To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopathy (TG) within 6 months.
Expanding Patient Applicability with Polymer Sealing Ovation Alto Stent Graft IDE Study (ELEVATE IDE STUDY)
ELEVATE: An abdominal aortic aneurysm is a bulge in the aorta (the main artery leaving the heart) caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow la…
ELEVATE: An abdominal aortic aneurysm is a bulge in the aorta (the main artery leaving the heart) caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and ultimately rupture (break open), resulting in serious internal bleeding. Treatment of your AAA with the Ovation Alto Abdominal Stent Graft System involves the placement of specially designed grafts (fabric tubes) in your aorta. The main graft looks like a pair of pants with very short legs. The top of the pants will be placed in your aorta. Then, two or more smaller grafts are used to extend from the main graft into your iliac arteries (the main arteries supplying blood to your abdomen and legs) to form the legs of the pair of pants. Each graft is enclosed in a small catheter (a long, flexible tube) that is inserted into your aorta through the femoral artery in your groin (top of your leg). The grafts are then placed in the correct position in your aorta by releasing them from the catheters. Once the grafts are attached inside your aorta, they will reinforce the area of your aorta that is weakened and bulging from your aneurysm. This procedure is called an endovascular aneurysm repair because the grafts are delivered through your blood vessels. The information collected from this study will be used to evaluate how well AAA patients do when treated with the investigational Ovation Alto Abdominal Stent Graft System both immediately after surgery and over a long period of time. The study device is investigational, which means that is has not been approved by the U.S. Food and Drug Administration (FDA) to treat your condition. If you decide to participate in this study, your medical condition will be carefully monitored. The study device is designed to treat a broader range of aneurysms by creating a seal higher in the aorta. The size and flexibility of this delivery system can potentially lower the risk of injury during device placement. Additionally, the seal that is gained between the graft and aorta can possibly reduce the risk of leaks and movement of the device. We expect about 10 people here will be in this research study out of 75 people in the entire study nationally. We expect that you will be in this research study for up to 12 months.