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Sponsored by: |
Abbott Vascular |
---|---|
Information provided by: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT00402740 |
The purpose of this study is two-fold:
Condition | Intervention |
---|---|
Carotid Artery Disease |
Device: Xact Stent with either Emboshield Pro or Emboshield (Gen 3) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | PROTECTed Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) |
Estimated Enrollment: | 320 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Category I - Anatomic Risk Factors
Category II - Co-morbid Risk Factors
Severe pulmonary disease, including at least one of the following: requires chronic O2 therapy; resting PO2 ≤ 60 mm Hg, Hematocrit ≥ 50%, FEV1 or DLCO
Exclusion Criteria
Study Chair: | Seemant Chaturvedi, MD | Wayne State University Stroke Program |
Study Chair: | William A Gray, MD | Columbia University College of Physicians and Surgeons |
Study Chair: | Jon Matsumura, MD | Northwestern University Feinberg School of Medicine |
Responsible Party: | Abbott Vascular ( Leah Green ) |
Study ID Numbers: | 640-0071 |
Study First Received: | November 20, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00402740 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Carotid Artery Disease Stent |
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 |