Research Trials in the Center for Vascular Disease
Researchers in Northwestern Memorial Hospital's Center for Vascular Disease at the Bluhm Cardiovascular Institute are conducting clinical research trials to learn more about treating vascular disease.
Clinical research trials search for new and better ways to understand and treat disease. Participating in a clinical research trial is an informative learning experience for the volunteer. Please consider volunteering in a clinical research trial as your participation will contribute to important advancements of medical knowledge. The following clinical research trial(s), specific to vascular disease, are currently recruiting volunteers:
Prospective, Multicenter, Randomized Controlled Trial of Endovascular Aneurysm Repair Using a Bilateral Percutaneous Approach (PEVAR) vs. Standard Approach (SEVAR) Using the IntuiTrak Endovascular AAA Delivery System and Prostar XL or ProGlide Suture Mediated Closure | |
| Principal Investigator: | |
| Mark D. Morasch, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00018632 | |
| Description of Research Trial: | |
This research study is recruiting individuals who have been diagnosed with an abdominal aortic aneurysm (AAA). The aorta is a large artery (blood vessel) that carries blood away from the heart to organs in the rest of the body. An aneurysm is caused by a weakening in the wall of the blood vessel. The growth of the aneurysm may seriously affect other major blood vessels in the area. The purpose of this research study is to assess the safety and effectiveness of PEVAR (percutaneous entry, a small incision 1-2cm in size) compared to SEVAR (standard cut-down entry, an incision 4-6cm in size) using the Powerlink stent graft with the 21French IntuiTrak endovascular delivery system for AAA repair. All subjects will undergo either the PEVAR or SEVAR technique. All subjects will have their AAA treated using the IntuiTrak Endovascular AAA Delivery System. PEVAR procedures will be performed with the use of Prostar XL for closing procedures of the femoral artery access site. This trial will evaluate the safety and effectiveness of this device in the closure of femoral artery access sites. Follow-up will occur at 1 month and 6 months and will include a physical exam, brief questionnaire as well as a CT scan, x-ray of the stent graft, and an ultrasound of the femoral artery. 210 subjects will be enrolled in this research study at up to 20 medical centers in the United States. A maximum of 25 subjects will enroll at Northwestern University. | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact Michelle Endo, CCRP at (312) 695-2928 or e-mail mendo@nmh.org | |
Carotid Stenting For High Surgical Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence ("CHOICE") | |
| Principal Investigator: | |
| Mark K. Eskandari, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00018373 | |
| Description of Research Trial: | |
The CHOICE study is recruiting individuals with a blockage, or stenosis, of the carotid artery that will be treated with a stent and an embolic protection system. A stent is an elastic-like metal tube that is used to hold open a narrow part of a blood vessel. An embolic protection system is a wire mesh basket designed to catch material (blood clots, fatty material) that could break off from the narrowed area of the blood vessel during the carotid stenting procedure. Subjects will receive either the RX Acculink® Carotid Stent System or the Xact® Rapid Exchange Carotid Stent System and either the RX Accunet™ Embolic Protection System or Emboshield® BareWire™ Rapid Exchange Embolic Protection System or Emboshield® NAV6 Emboshield Protection System. All of these devices have been approved/cleared by the US Food and Drug Administration (FDA). The purpose of this study is to collect data about patients' medical experiences and conditions following treatment of carotid stenosis using one of Abbott Vascular's carotid stent systems and embolic protection systems. It is expected that approximately 15,000 patients will take part in the study at up to 500 hospitals in the United States. | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact Michelle Endo, CCRP at (312) 695-2928 or e-mail mendo@nmh.org | |
SAPPHIRE WW - Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy | |
| Principal Investigator: | |
| Mark K. Eskandari, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00018716 | |
| Description of Research Trial: | |
This study is enrolling patients who will be undergoing carotid stent supported angioplasty using PRECISE® Stent System and ANGIOGUARD™ XP/RX. This procedure treats a narrowed artery in the neck called the carotid artery, which supplies blood to the brain. This condition has either produced symptoms that include small strokes, or if without symptoms, could cause a future stroke. Carotid stent supported angioplasty is an approved procedure being offered as an alternative to carotid artery surgery for narrowed carotid arteries. Angioplasty (a balloon catheter technique) is an effective method of opening the blood vessels in the heart and legs. A stent is a mettalic device that behaves like a spring to keep the artery open. The devices that will be used are the Cordis PRECISE® Nitinol Stent System and the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW). Both of these devices have been approved by the Food and Drug Administration (FDA). Other PRECISE® stents that are approved for use by the FDA in the future may also be used. This study will collect information about the devices in 15,000 patients in North America. Approximately 70 patients will participate at Northwestern University. | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact Eileen McDonald at (312) 695-3410 or e-mail emcdona1@nmh.org | |
Descending Thoracic Aortic Aneurysm Endovascular Repair Post Approval Study ("THRIVE") | |
| Principal Investigator: | |
| Heron E. Rodriguez, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00008276 | |
| Description of Research Trial: | |
This post market clinical study is recruiting patients who have a decsending thoracic aneurysm that is being treated with the Talent Thoracic Stent Graft System. For this research study, Medtronic Vascular, Inc. (the study sponsor) is collecting information about the Talent Thoracic Stent Graft System. The purpose of the study is to evaluate the long-term performance of the Talent Thoracic Stent Graft System to gain additional information regarding the safety and efficacy of it. The Talent Thoracic Stent Graft System, manufactured by Medtronic, has been approved by the US Food and Drug Administration ("FDA") for the treatment of descending thoracic aortic aneurysms. Up to 256 subjects will be enrolled in this research study at a minimum of 15 medical centers in the United States. Approximately 35 subjects may be enrolled at Northwestern University. | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact Michelle Endo, CCRP at (312) 695-2928 or e-mail mendo@nmh.org | |
A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation™ Abdominal Stent Graft System | |
| Principal Investigator: | |
| Mark K. Eskandari, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00024852 | |
| Description of Research Trial: | |
This study is enrolling subjects diagnosed with an abdominal aortic aneurysm which requires surgery. This study is designed to determine the safety and effectiveness of the Ovation™ Abdominal Stent Graft System, an investigational device (not approved by the FDA for general use; can be used only in this research study) used in the treatment of abdominal aortic aneurysms (AAA). 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. The information collected from this study will be used to evaluate how well patients do when treated with the Ovation™ Abdominal Stent Graft System (study device) both immediately after surgery and over a long period of time (five years). This research study will be conducted at approximately 40 clinical sites and will enroll up to 150 patients. Up to 30 subjects will be enrolled at Northwestern. | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact Eileen McDonald at (312) 695-3410 or e-mail emcdona1@nmh.org | |
Evaluation of the clinical performance of the Valiant® Thoracic Stent Graft with the Captivia Delivery System for the treament of acute, complicated Type B Aortic Dissections | |
| Principal Investigator: | |
| Mark K. Eskandari, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00022884 | |
| Description of Research Trial: | |
This research study is looking for individuals to participate in this study who have been diagnosed with an acute complicated Type B aortic dissection. The aorta is a large artery (blood vessel) that carries blood away from your heart to organs in the rest of your body. A dissection is a condition where the inside layer of the aorta tears, allowing blood to enter between the vessel walls. When the blood enters into the walls it cannot reach the organs effectively. If the blood continues to fill the walls, pressure can build-up and the wall of your aorta is in danger of breaking open. The purpose of this research study is to assess the safety and effectiveness of an investigational stent graft when used to treat dissections of the descending thoracic aorta. Follow-up will occur at 1, 6, 12, 24, 36, 48, and 60 months and will include a physical exam as well as a CT scan and x-ray of your chest, abdomen and pelvis. "Caution - INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE." | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact Michelle Endo, CCRP at (312) 695-2928 or e-mail mendo@nmh.org | |
The Lifestyle Interventions and Independence for Elders Study (The LIFE Study) | |
| Principal Investigator: | |
| Mary McGrae McDermott, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00020824 | |
| Description of Research Trial: | |
We are seeking participants 70 to 89 years old who do not engage in regular exercise or physical activity and experience some difficulty with balance and mobility. The purpose of this research study is to determine whether regular exercise and physical activity helps prevent mobility loss later in life. Participants will be assigned to either a Physical Activity Program or Healthy Aging classes. Participants in the Physical Activity Program will work an exercise trainer during exercise classes twice weekly. Participants in the Healthy Aging Program will attend weekly lectures on topics related to aging. Transportation may be available; costs of transportation or parking reimbursed; monetary compensation is available for completing testing. | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact Kasia Kadela at (312) 503-3324 or e-mail katarzynakadela2007@u.northwestern.edu | |
Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection (Clinical Study) TAG 08-01 | |
| Principal Investigator: | |
| Heron E. Rodriguez, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00009909 | |
| Description of Research Trial: | |
This research study is looking for individuals to participate in this study who have been diagnosed with an acute complicated type B aortic dissection. The aorta is a large artery (blood vessel) that carries blood away from your heart to organs in the rest of your body. A dissection is a condition where the inside layer of the aorta tears, allowing blood to enter between the vessel walls. When the blood enters into the walls it cannot reach the organs effectively. If the blood continues to fill the walls, pressure can build-up and the wall of your aorta is in danger of breaking open. The purpose of this research study is to assess the safety and effectiveness of an investigational stent when used to treat dissections of the descending thoracic aorta. Follow-up will occur at 1, 6, 12, 24, 36, 48 and 60 months and will include a physical exam as well as a CT scan and x-ray of the stent graft. | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact Eileen McDonald at (312) 695-3410 or e-mail emcdona1@nmh.org | |
Carotid Angioplasty and Stenting versus Endarterectomy in Asymptomatic Subjects with Significant Extracranial Carotid Occlusive Disease ACT 1 | |
| Principal Investigator: | |
| Mark K. Eskandari, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00014105 | |
| Description of Research Trial: | |
ACT I is sponsored by Abbott Vascular Devices and is a randomized, controlled, multi-center trial to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield Cerebral Protection System with the Xact RX Carotid Stent System when compared to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid stenotic disease. To participate in this study, the participant must not have had a stroke or TIA (transient ischemic attack or mini stroke) within the last 6 months and have carotid artery stenosis (narrowing) > 80%. The participant must be less than 80 years old and also not have any medical condition, such as advanced congestive heart failure, unstable angina or severe lung disease, which deems them a high surgical risk. Other exclusion criteria may apply. Follow-up will occur at 30 days, 6 months and annually up to 5 years after the procedure and may include a physical and neurological examination, laboratory tests and a carotid ultrasound. The Emboshield(tm) Bare Wire Rapid Exchange (RX) Cerebral Protection System is designed to reduce distal embolization while maintaining blood flow during angioplasty and stent procedures. The Xact(tm) Rapid Exchange (RX) Carotid Stent System is intended for use during an interventional carotid artery stent procedure. The Xact stent is a permanently implantable device and is intended to re-establish and maintain vessel patency. The Xact RX Carotid Stent System is indicated for use in conjunction with the Emboshield Cerebral Protection System. "Caution - INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE." | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact Michelle Endo, CCRP at (312) 695-2928 or e-mail mendo@nmh.org | |
A Pilot Study of the Prevalence of Inflammatory Mediator Gene Polymorphisms and Corresponding Circulating Protein Levels in Abdominal Aortic Aneurysm Patients | |
| Principal Investigator: | |
| William H. Pearce, MD (profile opens in new window) | |
| IRB Project Number: | |
| STU00025048 | |
| Description of Research Trial: | |
| This research study is looking for participants who have one of the following diseases: abdominal aortic aneurysm, aortic dissection or carotid disease. The objective of this study is to identify naturally occurring variations in the DNA sequences, or polymorphisms, of genes that regulate the immune response and are associated in abdominal aortic aneurysm (AAA) patients versus patients with carotid artery disease, aortic dissection and a population of healthy age- and ethnically-matched controls. Plasma protein levels from the corresponding genes will also be analyzed. Participants will have 1 outpatient visit where 4 teaspoons of blood will be drawn. | |
| Research Trial Contact Information: | |
| For more information, interested participants and clinicians may contact the Clinical Trials Unit at (312) 926-4000 or e-mail heartresearch@northwestern.edu |
