CHOICE: Carotid Stenting For High Surgical-Risk Patients

NCT00406055 | Completed

• 1 other identifier: 06-717
• Study Type: observational
• Target: 18,855
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study is to 1) Provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions. 2) Provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.

Conditions

Carotid Artery Disease

Outcome Measures

Primary Outcomes (1)

• Composite of death, stroke, and MI (DSMI)

  30 days

Study Arms (1)

1

Provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.

Device: RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6

Interventions

RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6 DEVICE

Provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled into this registry will be male and female patients derived from the general population who satisfy the inclusion and exclusion criteria.

You may qualify if:

• Patient or patient's legally authorized representative provided informed consent.
• Patient is considered at high risk for carotid endarterectomy (CEA).
• Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
• Patients physician intends to use an RX Acculink with either the RX Accunet or Emboshield Nav 6 in the carotid artery OR the patients physician intends to use an Xact with the Emboshield or Emboshield Nav6 in the carotid artery as per the FDA approved Indications for Use as outlined.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• William Gray, M.D.

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

US (1)