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Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™

Study:

Carotid Artery Revascularization Using the Boston Scientific EPI Filter Wire EZ™ and the EndoTex™ NexStent™

Rationale:

n/a

Purpose:

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.

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Transient Ischemic Attack
Thromboembolic Stroke
Stroke Prevention
Device: EndoTex™ NexStent™
Device: Filter Wire EZ™
Phase 3

Verified by Boston Scientific Corporation January, 2008

Sponsored by: Boston Scientific Corporation
Information provided by: Boston Scientific Corporation
ClinicalTrials.gov identifier: NCT00600327

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Cheryl Fontana, BSN., Study Director
L. Nelson Hopkins, MD., Principal Investigator
Subbarao Myla, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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