NCT00180492

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

October 27, 2008

Conditions

Atherosclerotic Disease, Carotid

Keywords

Atherosclerotic disease

Outcome Measures

Primary Outcomes (1)

  • Death, stroke, and myocardial infarction at 30 days post-procedure.

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient's physician used an ACCULINK and/or ACCUNET

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guidant Corporation

Santa Clara, California, 95054, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gary A Walker, PhD

    Abbott Medical Devices

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2006

Study Completion

August 1, 2007

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

US(1)