NCT00302237

Brief Summary

The purposes of the registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Longer than P75 for all trials

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

March 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

4 years

First QC Date

March 10, 2006

Last Update Submit

December 12, 2012

Conditions

Carotid Artery Disease

Keywords

carotid, stenting, angioplasty

Outcome Measures

Primary Outcomes (1)

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

    at 30 days

Study Arms (1)

1

1\) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program.

Device: RX ACCULINK, RX ACCUNET Embolic Protection System

Interventions

RX ACCULINK, RX ACCUNET Embolic Protection SystemDEVICE

1\) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program.

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Open-ended enrollment at approximately 400 clinical sites in the United States.

You may qualify if:

  • Informed Consent for data collection.
  • Intent to use the RX ACCULINK and RX ACCUNET to treat carotid artery disease.

You may not qualify if:

  • none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

Related Publications (2)

  • Gray WA, Rosenfield KA, Jaff MR, Chaturvedi S, Peng L, Verta P; CAPTURE 2 Investigators and Executive Committee. Influence of site and operator characteristics on carotid artery stent outcomes: analysis of the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) clinical study. JACC Cardiovasc Interv. 2011 Feb;4(2):235-46. doi: 10.1016/j.jcin.2010.10.009.

    PMID: 21349464DERIVED

  • Matsumura JS, Gray W, Chaturvedi S, Gao X, Cheng J, Verta P; CAPTURE 2 Investigators and Executive Committee. CAPTURE 2 risk-adjusted stroke outcome benchmarks for carotid artery stenting with distal embolic protection. J Vasc Surg. 2010 Sep;52(3):576-83, 583.e1-583.e2. doi: 10.1016/j.jvs.2010.03.064. Epub 2010 Jun 23.

    PMID: 20576398DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • William Gray, M.D.

    Executive Committee Member

    STUDY DIRECTOR

  • Jaysinghe Yadav, M.D.

    Executive Committee Member

    STUDY DIRECTOR

  • Richard Atkinson, M.D.

    Executive Committee Member

    STUDY DIRECTOR

  • Ronald Fairman, M.D.

    Executive Committee

    STUDY DIRECTOR

  • Mark Wholey, M.D.

    Executive Committee Member

    STUDY DIRECTOR

  • Rod Raabe, M.D.

    Executive Committee Member

    STUDY DIRECTOR

  • Richard Green, M.D.

    Executive Committee Member

    STUDY DIRECTOR

  • Nick Hopkins, M.D.

    Executive Committee Member

    STUDY DIRECTOR

  • Stan Barnwell, M.D.

    Executive Committee Member

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 14, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

US(1)