Trials / Completed
CompletedNCT00231231
Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,500 (planned)
- Sponsor
- Cordis US Corp. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | -PRECISE Nitinol Stent System (5F, 5.5F and 6F) | |
| DEVICE | ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW) |
Timeline
- Start date
- 2004-09-01
- Completion
- 2006-11-01
- First posted
- 2005-10-04
- Last updated
- 2007-07-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00231231. Inclusion in this directory is not an endorsement.