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Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)

NCT00231231 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2007-07-20

No results posted yet for this study

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 during peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).

Conditions

  • Carotid Artery Disease

Interventions

DEVICE

-PRECISE Nitinol Stent System (5F, 5.5F and 6F)

DEVICE

ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Sidney A. Cohen, MD, PhD · Cordis Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-09-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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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 NCT00231231 on ClinicalTrials.gov