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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. The following clinical research trials, specific to vascular disease, are currently recruiting volunteers. 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. |
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| Name of Research Trial: | Iliac Stent Pivotal Study |
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| Principal Investigator: | Mark Eskandari, MD |
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| IRB Project Number: | 1038-031 |
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| Description of Research Trial: | This research study is looking for individuals to participate in this study because they have been diagnosed with a condition known as symptomatic claudication, which patients may have noticed as pain in the legs. Some patients with peripheral arterial disease (PAD) experience leg pain while at rest. This may be due to limited blood flow to the affected leg by a constriction (narrowing) of the arteries that run through the ilium, which is part of the pelvis. A common procedure used to treat your condition involves placing a stent in the area that is blocked to improve blood flow to the leg. The purpose of this study is to evaluate the safety and effectiveness of an investigational stent when compared to other approved iliac artery stents. Follow-up will occur at 1, 6, 9, 12, 24 and 36 months after procedure and will include a physical exam and blood pressures of the arm and leg. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Meadows, BSN, RN at (312) 695-2928 or e-mail wmeadows@nmh.org or Mary Evans, BSN, RN at (312) 695-3410 or e-mail mevans@nmh.org |
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| Name of Research Trial: | The US Study for Evaluating Endovascular Treatments of Lesions in the Superficial Femoral Artery and Proximal Popliteal by Using Protege Everflex Nitinol Stent System III - DURABILITY II |
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| Principal Investigator: | Mark Eskandari, MD |
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| IRB Project Number: | 1038-029 |
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| Description of Research Trial: | This research study is looking for individuals who have been diagnosed with a narrowing in the arteries that are located in your leg between the groin and the knee, resulting in poor blood flow to the leg. This study place an investigational stent (Protege Everflex) in the area of narrowing in the leg to help keep the artery open.
The purpose of this study is to evaluate the safety and efficacy of the stent. Follow-up will occur at 1, 3, 6, 12, 24, 36, 48 and 60 months after procedure and will include questionnaires, ultrasound and x-rays of the stent. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Meadows, BSN , RN at (312-695-2928) or e-mail wmeadows@nmh.org or Mary Evans, BSN, RN at (312) 695-3410 or e-mail mevans@nmh.org |
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| Name of Research Trial: | The Embolic Protection with Reverse Flow (EMPiRE) Study of the GORE Neuro Protection System in Carotid Stenting of Subjects at High Risk for Carotid Endarterectomy |
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| Principal Investigator: | Mark Eskandari, MD |
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| IRB Project Number: | 1038-020 |
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| Description of Research Trial: | This research study is looking for individuals who have been diagnosed with a carotid artery narrowing:
> 80 % narrowing, with no neurological symptoms and are surgically at high-risk
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> 50% narrowing, with neurological symptoms and are surgically at high-risk
The Gore Neuro Protection System is intended to provide embolic protection during carotid artery angioplasty and stenting for subjects diagnosed with carotid artery stenosis and who have appropriate anatomy. The purpose of this study is to evaluate the safety and efficacy of Gore Neuro Protection System in the treatment of carotid artery disease with patients at high risk for carotid endarterectomy. Follow-up will occur at 1 month after procedure and will include a physical and National Institute of Health Stroke Scale, and a carotid ultrasound. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Meadows, BSN, RN at (312) 695-2928 or e-mail wmeadows@nmh.org or Mary Evans, BSN, RN at (312) 695-3410 or e-mail mevans@nmh.org |
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| Name of Research Trial: | A Clinical Study Evaluating the Use of the GORE EXCLUDER Bifurcated Endoprosthesis- 31 mm in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms (AAA) |
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| Principal Investigator: | Mark D. Morasch, MD |
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| IRB Project Number: | 0362-020 |
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| Description of Research Trial: | This research study is looking for individuals with > 4.5 cm infrarenal abdominal aortic aneurysm. The purpose of this study is to evaluate the 31 mm GORE EXCLUDER Bifurcated Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms. Participation in this study will involve a screening visit, overnight stay for the procedure and 7 clinic visits over 5 years |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Meadows, BSN, RN at (312) 695-2928 or e-mail wmeadows@nmh.org or Mary Evans, BSN, RN at (312) 695-3410 or e-mail mevans@nmh.org |
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| Name of Research Trial: | Hematopoietic Stem Cell Transplantation for Peripheral Vascular Disease: Induction of Neoangiogenesis |
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| Principal Investigators: | Richard K. Burt, MD |
| William H. Pearce, MD |
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| IRB project: | 0141-037 |
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| Description of Research Trial: | This study is recruiting individuals with severe peripheral vascular disease manifested with ABI <0.8, ulcerations in legs, pain at rest and are not surgical candidates for bypass graft. Purpose of this study is to evaluate whether stem cells will repair and/or create new vessels in the leg and improve blood flow. Follow up visits will be 5 days post injection of stem cells and 1, 3, 6 and 12 months post stem cell injection. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Kimberly Yaung, Clinical Nurse Research Coordinator at (312) 503-1435 or email kyaung@nmff.org |
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| Name of Research Trial: | Improving Functioning in Peripheral Arterial Disease |
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| Principal Investigator: | Mary M. McDermott, MD |
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| IRB Project Number: | 344-0081 |
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Description of Research Trial:
| Men and women with Peripheral Arterial Disease may qualify for the study. Most participants get free exercise sessions 3 times a week with a trainer. Most transportation reimbursed. Participation may require up to three visits a week for six months. Length of participation: one year. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Catharine Smith, Project Coordinator at (312) 695-1095 or e-mail c-smith@northwestern.edu |
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| Name of Research Trial: | Carotid Revascularization Endarterectomy vs. Stent Trial (CREST) |
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| Principal Investigator: | Mark K. Eskandari, MD |
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| IRB Project Number: | 1038-004 |
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| Description of Research Trial: | This research study is looking for individuals who have been diagnosed with a carotid artery stenosis. The purpose of the study is to evaluate Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA) in preventing stroke, myocardial infarction (MI), and death in symptomatic and asymptomatic patients. Participation in this study will involve a screening visit, overnight stay at Northwestern Memorial Hospital for the procedure and outpatient visits at 1, 6, 12, 18, 24, 36 and 48 months along with telephone contacts that will occur at 3 month intervals until 48 months. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Meadows, BSN, RN at (312) 695-2928 or e-mail wmeadows@nmh.org or Mary Evans, BSN, RN at (312) 695-5020 or e-mail mevans@nmh.org |
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| Name of Research Trial: | Atherosclerotic Plaque Characterization Using High-field MRI |
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| Principal Investigators: | Timothy Carroll, PhD |
| Mark D. Morasch, MD |
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| IRB Project Number: | 1334-002 |
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| Description of Research Trial: | This research study is looking for participants who have a build up of plaque in the carotid artery. The purpose of this research study is to look at the ability of magnetic resonance imaging (MRI) to detect the composition of the plaque inside the artery. If a participant needs to have the plaque removed by carotid endarterectomy the plaque will be sent to pathology for further analysis. Participates will undergo a MRI scan during a single visit that will last approximately 2 hours at Northwestern Memorial Hospital, Center for Advanced Magnetic Resonance Imaging. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Meadows, BSN, RN at (312) 695-2928 or e-mail wmeadows@nmh.org or Mary Evans, BSN, RN at (312) 695-5020 or e-mail mevans@nmh.org |
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| Name of Research Trial: | Carotid Angioplasty and Stenting versus Endarterectomy in Asymptomatic Subjects with Significant Extracranial Carotid Occlusive Disease ACT 1 |
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| Principal Investigator: | Mark K. Eskandari, MD |
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| IRB Project Number: | 1038-014 |
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| 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. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Meadows, BSN, RN at (312) 695-2928 or e-mail wmeadows@nmh.org or Mary Evans, BSN, RN at (312) 695-5020 or e-mail mevans@nmh.org |
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| Name of Research Trial: | A Pilot Study of the Prevalence of Inflammatory Mediator Gene Polymorphisms and Corresponding Circulating Protein Levels in Abdominal Aortic Aneurysm Patients |
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| Principal Investigator: | William H. Pearce, MD |
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| IRB Project Number: | 0391-022 |
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| 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. |
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| Research Trial Contact Information: | For more information, interested participants and clinicians may contact Wendy Meadows, BSN, RN at (312) 695-2928 or e-mail wmeadows@nmh.org or Mary Evans, BSN, RN at (312) 695-5020 or e-mail mevans@nmh.org |
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