Study:
Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
Rationale:
n/a
Purpose:
The primary objective of this study is to assess the outcomes of stenting with distal
protection in the treatment of obstructive carotid artery disease during
peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical
Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis
ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Carotid Artery Disease |
Device: -PRECISE Nitinol Stent System (5F, 5.5F and 6F) Device: ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW) |
Phase 3 |
Verified by
Cordis Corporation
July, 2007
Sponsored by: Cordis Corporation
Information provided by: Cordis Corporation
ClinicalTrials.gov identifier: NCT00231231
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Cleveland Clinic
Cleveland, Ohio 44195
United States
Sidney A. Cohen, MD, PhD., Study Director