Northwestern University Feinberg School of Medicine

Department of Surgery

Clinical Trials

As part of an academic medical center, the Division of Vascular Surgery within 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.

Division of Vascular Surgery, Department of Surgery
The following searchable list includes all the Division of Vascular Surgery, Department of Surgery clinical trials currently looking for participants.

Contact Us
Please feel free to contact us with inquiries about any of our ongoing research.

Trials
Gore TAG-TBE
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). Blo…
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.
Primary Inclusion Criteria: 

  • 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. 
Primary Exclusion Criteria: 

  • 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 
  • Myocardial infarction within 6 weeks prior to treatment 
  • Stroke within 6 weeks prior to treatment. 

Hoel, AndrewHoel, Andrew
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02777593 STU00203850
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For more information on this study please contact us:

Reinkensmeyer, Alexandra
Bolton RelayPro
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 tu…
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.
Inclusion Criteria: 

  • Subject must have an acute (symptom onset to diagnosis within 2 weeks) or 
  • Subacute, complicated type B aortic dissection 
  • Proximal and distal aortic neck with diameter between 19 mm and 42 mm. 
Exclusion Criteria: 

  • 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.

Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03033043 STU00204570
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For more information on this study please contact us:

Brady, Caitlin
AAA Geometric Surrogates
An Abdominal Aortic Aneurysm (AAA) is a balloon-like expansion of the aorta, the large artery that transports blood from the heart to the rest of the body, in the abdominal area just below the kidneys. As part of routine monitoring care for patients diagnosed with AAA, at lea…
An Abdominal Aortic Aneurysm (AAA) is a balloon-like expansion of the aorta, the large artery that transports blood from the heart to the rest of the body, in the abdominal area just below the kidneys. As part of routine monitoring care for patients diagnosed with AAA, at least semi-annual evaluations are performed using imaging methods such as a computed tomography (CT) scan. Magnetic Resonance Imaging (MRI) is another method of creating pictures of the same vessels seen on a CT scan. MRI is a method for producing extremely detailed pictures of blood vessels without the need for x-rays. Radio waves, along with the magnetic field of a large magnet within the MRI machine, are used to make the pictures. MR images are used to detect and aid in the diagnosis of heart disorders and blood vessel diseases. For the purpose of this research, along with the routine CT scan, an additional scan called a ECG-gated MRI exam will be performed. This MRI exam does not involve any contrast, a dye used to make tissues, abnormalities or diseases processes more visible. This one-time MRI exam will be performed prior to anticipated elective AAA repair or during the course of periodic surveillance for AAA. This research study plans to enroll approximately 200 study participants at approximately 3 sites, including approximately 100 people at Northwestern.
Participants may be eligible for this study if they have been diagnosed with an Abdominal Aortic Aneurysm and either have been recommended to undergo elective repair or are currently under periodic surveillance for AAA.
Eskandari, MarkEskandari, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
STU00205143
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For more information on this study please contact us:

Reinkensmeyer, Alexandra