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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00403078
Other study ID # P06-3603
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2006
Est. completion date November 2014

Study information

Verified date August 2020
Source Cordis Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. 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).


Description:

Carotid Artery Stenting


Recruitment information / eligibility

Status Completed
Enrollment 21008
Est. completion date November 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Massop D, Dave R, Metzger C, Bachinsky W, Solis M, Shah R, Schultz G, Schreiber T, Ashchi M, Hibbard R; SAPPHIRE Worldwide Investigators. Stenting and angioplasty with protection in patients at high-risk for endarterectomy: SAPPHIRE Worldwide Registry fir — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Any death, stroke or any MI up to 30-days post-procedure
Secondary Assess the consistency of MAE rates of stenting with distal protection in the treatment of obstructive carotid artery disease among high, medium and low volume centers with physicians who have validated CASES training levels of 1, 2, 2P or 3 30 days
Secondary Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled Every follow-up where a PRO instrument QoL was assessed
Secondary Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment 1 year
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