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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00600327 |
The primary objective of this study is to demonstrate the safety of the NexStent for treatment of carotid artery lesions undergoing stenting with adjunctive use of the FilterWire distal embolic protection device. The rates will be compared to an Objective Performance Criterion (OPC) derived from historic data from high-risk patients undergoing surgical intervention with Carotid endarterectomy. Patients included in this study are those at higher risk for complications associated with CEA.
Condition | Intervention | Phase |
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Transient Ischemic Attack Thromboembolic Stroke Stroke Prevention |
Device: EndoTex™ NexStent™ Device: Filter Wire EZ™ |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™ |
Enrollment: | 488 |
Study Start Date: | December 2001 |
Study Completion Date: | June 2007 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Device: EndoTex™ NexStent™
EndoTex™ NexStent™ is a flexible, fine mesh Nitinol stent used to treat patients that are at high risk of adverse events from carotid endarterectomy and require carotid revascularization of a target vessel that has a reference diameter between 4mm and 9mm and stenosis that is less than 30mm in length.
Device: Filter Wire EZ™
EPI Fliter Wire EZ™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation (AVM) of the cerebral vasculature.
United States, Arizona | |
St. Joseph's Hospital and Medical Center | |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
Hoag Hospital | |
Newport Beach, California, United States, 92663 | |
El Camino Hospital | |
Mountain View, California, United States, 94040 | |
United States, Louisiana | |
Oschner Clinic Foundation | |
New Orleans, Louisiana, United States, 70121 | |
United States, Maryland | |
Union Memorial Hospital | |
Baltimore, Maryland, United States, 21218 | |
United States, New York | |
Millard Fillmore Gates Hospital | |
Buffalo, New York, United States, 14209 | |
Lenox Hill Hospital | |
New York, New York, United States, 10021 | |
Albany Medical College | |
Albany, New York, United States, 12208 | |
Columbia - Weill Cornell Division of Vascular Surgery | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Carolina Medical Center | |
Charlotte, North Carolina, United States, 28203 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
University of Pittsburgh (UPMC-Shadyside) | |
Pittsburgh, Pennsylvania, United States, 15232 | |
Harrisburg Hospital | |
Harrisburg, Pennsylvania, United States, 17101 | |
Allegheny General Hospital | |
Pittsburg, Pennsylvania, United States, 15212 | |
United States, Washington | |
Swedish Medical Center | |
Seattle, Washington, United States, 98104 | |
Argentina | |
Favaloro Institute | |
Buenos Aires, Argentina, 1093 | |
Germany | |
Sieburg Heart Center, Germany | |
Siegburg, Germany, 53721 | |
Cardiovascular Center Bethanien, Germany | |
Frankfurt, Germany, 60389 | |
Leipzig Heart Center | |
Leipzig, Germany, 04289 |
Study Director: | Cheryl Fontana, BSN | Boston Scientific Corporation |
Principal Investigator: | L. Nelson Hopkins, MD | Millard Filmore/Gates Hospital |
Principal Investigator: | Subbarao Myla, MD | Hoag Hospital |
Responsible Party: | Boston Scientific ( Cheryl Fontana ) |
Study ID Numbers: | S2209 |
Study First Received: | January 14, 2008 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00600327 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Stroke thrombosis thromboembolic Transient Ischemic Attack TIA |
Ischemic Attack, Transient Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Brain Ischemia |
Brain Infarction Ischemia Brain Diseases Infarction Cerebrovascular Disorders Thrombosis |
Ischemic Attack, Transient Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Brain Ischemia Cardiovascular Diseases Brain Infarction Brain Diseases Cerebrovascular Disorders |