Trials / Completed
CompletedNCT00231270
Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,300 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cordis Nitinol Stent | |
| DEVICE | PRECISE tapered stent | |
| DEVICE | ANGIOGUARD XP Emboli Capture Guidewire (ECGW) |
Timeline
- Start date
- 2000-08-01
- Completion
- 2005-08-01
- First posted
- 2005-10-04
- Last updated
- 2008-04-24
Source: ClinicalTrials.gov record NCT00231270. Inclusion in this directory is not an endorsement.