SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

Completed

Conditions studied: Carotid Artery Disease

In brief

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).

Key facts

Study ID

NCT00403078

Run by

Cordis US Corp.

People needed

21008

Starts

2006-10-01

Expected to finish

2014-11-01

Last updated by the study team

2020-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Christiana Care Health Services — Newark, Delaware, United States
• Iowa Clinic, Heart & Vascular Care — West Des Moines, Iowa, United States
• Bryan LGH Heart Institute — Lincoln, Nebraska, United States
• Harrisburg Hospital — Harrisburg, Pennsylvania, United States
• The Heart Center, PC — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.