SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2006 |
| End Date: | November 2014 |
| Contact: | Clinical Trial Triage |
| Phone: | 877-820-TRIAL |
Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)
The primary objective of this study is to assess the outcomes of stenting with distal
protection in the treatment of obstructive carotid artery disease. The devices to be
utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis
ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
protection in the treatment of obstructive carotid artery disease. The devices to be
utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis
ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
Carotid Artery Stenting
Inclusion Criteria:
- High-surgical risk patients to be treated consistent with IFU labeling
- The patient or legally authorized representative has signed a written informed
consent and HIPAA authorization, prior to the procedure, using a form that is
approved by the Institutional Review Board or Medical Ethics Committee.
Exclusion Criteria:
- Patients not treated per the IFU
- Patients who are contraindicated per the IFU
- Patients previously enrolled in the study
- Patients requiring stenting of in-stent restenosis after CAS
- Inability or refusal to provide informed consent.
We found this trial at
5
sites
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