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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00231270 |
The primary objective of this study is to compare the safety and effectiveness of the Cordis Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal protective device to CEA in the treatment of carotid artery disease in patients at increased risk for surgery.
Condition | Intervention | Phase |
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Carotid Artery Disease |
Device: Cordis Nitinol Stent Device: PRECISE tapered stent Device: ANGIOGUARD XP Emboli Capture Guidewire (ECGW) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy |
Estimated Enrollment: | 1300 |
Study Start Date: | August 2000 |
Study Completion Date: | August 2005 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as:
To be entered into the study, the patient must have one or more of the following conditions:
Exclusion Criteria:
Study ID Numbers: | P98-5201 |
Study First Received: | October 3, 2005 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00231270 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Vascular Diseases Central Nervous System Diseases Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |
Nervous System Diseases Vascular Diseases Central Nervous System Diseases Cardiovascular Diseases |
Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |