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

This study has been completed.
Sponsor:
Collaborator:
Guidant Corporation
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00180492
First received: September 13, 2005
Last updated: October 27, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention
Atherosclerotic Disease, Carotid
Device: RX ACCULINK(TM) Carotid Stent System and RX ACCUNET(TM) Embolic Protection System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Carotid RX ACCULINK(TM)/ACCUNET(TM) Post-Approval Trial to Uncover Unanticipated or Rare Events - CAPTURE

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Death, stroke, and myocardial infarction at 30 days post-procedure.

Estimated Enrollment: 1500
Study Start Date: October 2004
Study Completion Date: August 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient's physician used an ACCULINK and/or ACCUNET
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180492

Locations
United States, California
Guidant Corporation
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Guidant Corporation
Investigators
Study Chair: Gary A Walker, PhD Abbott Vascular
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180492     History of Changes
Other Study ID Numbers: 04-715
Study First Received: September 13, 2005
Last Updated: October 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Atherosclerotic disease

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014