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Post-Approval Study of the Guidant Carotid Stent Systems and Embolic Protection Systems: CAPTURE

NCT ID: NCT00180492

Last Updated: 2008-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-08-31

Brief Summary

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This purpose of this study is to collect data on the FDA-approved ACCULINK(TM) Carotid Stent System and FDA 510(k)-cleared ACCUNET(TM) Embolic Protection System for the treatment of patients with atherosclerotic disease, when used by physicians under commercial use conditions.

Detailed Description

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CAPTURE is a post-approval study to collect information on the safety and effectiveness of the ACCULINK and ACCUNET since the approval/clearance of these devices by the FDA. The ACCULINK stent is an elastic-like metal tube that is used to hold open a narrow part of a blood vessel. The ACCUNET is a wire mesh basket that is placed in the vessel to catch material (blood clots, fatty material) that could break off from the narrowed area of the blood vessel and block blood flow downstream during the stent procedure.

Another goal of the CAPTURE study is to confirm that the ACCULINK and ACCUNET can be used safely by physicians with varying levels of experience in stenting procedures.

The basis for FDA's approval/clearance of the ACCULINK and ACCUNET was the ARCHeR trials (ACCULINK/ACCUNET for Revascularization of Carotids in High-Risk Patients). The ARCHeR trials were conducted to collect data on the safety and effectiveness of the ACCULINK and ACCUNET when used in the treatment of carotid artery disease in patients at high risk for surgical treatment (carotid endarterectomy) because of medical or surgical comorbidities. The ARCHeR trials showed that the ACCULINK, used with or without the ACCUNET, is a safe and effective treatment option based on the rate of death, stroke, and myocardial infarction at 30 days, and stroke at one year.

Conditions

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Atherosclerotic Disease, Carotid

Keywords

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Atherosclerotic disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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RX ACCULINK(TM) Carotid Stent System and RX ACCUNET(TM) Embolic Protection System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient's physician used an ACCULINK and/or ACCUNET
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guidant Corporation

INDUSTRY

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Principal Investigators

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Gary A Walker, PhD

Role: STUDY_CHAIR

Abbott Medical Devices

Locations

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Guidant Corporation

Santa Clara, California, United States

Site Status

Countries

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United States

Other Identifiers

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04-715

Identifier Type: -

Identifier Source: org_study_id