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Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)

NCT00231270 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2008-04-24

No results posted yet for this study

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

  • Carotid Artery Disease

Interventions

DEVICE

Cordis Nitinol Stent

DEVICE

PRECISE tapered stent

DEVICE

ANGIOGUARD XP Emboli Capture Guidewire (ECGW)

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-08-31
Completion
2005-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00231270 on ClinicalTrials.gov