CAPTURE 2 Post-Marketing Registry (CAPTURE 2)

Second Phase of "Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events"

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Disease
• Intervention / Treatment: Device: RX ACCULINK, RX ACCUNET Embolic Protection System

Detailed Description

CAPTURE 2 is an amendment to the CAPTURE study and will provide a mechanism for collection of data from the RX ACCULINK and RX ACCUNET Systems, when used by a broad group of physicians under commercial use conditions. The original CAPTURE study had built-in features that limited the ability to collect on-going real world data because it restricted the number of sites that could participate (up to 150 sites) and limited enrollment at each site (40 patients per site). CAPTURE 2 will not have these restrictions. CAPTURE 2 is a descriptive post-approval registry that will be conducted at approximately 400 clinical sites in the United States with open-ended enrollment. The purposes of this registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System (EPS) 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. As with the previous CAPTURE study, data will continue to be collected on any rare or unanticipated events that may occur. Patients in CAPTURE 2 will be followed after the index procedure to 30 days. During the 30 day follow-up period, any occurrence of death, stroke, myocardial infarction (MI), new neurologic events, and device-related adverse events will be reported to Abbott Vascular.

• Study Type: Observational
• Enrollment (Actual): 6426

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Clara, California, United States, 95054
      • Abbott Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

none.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of death, stroke, and MI (DSMI)	at 30 days

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 10, 2006
• First Submitted That Met QC Criteria: March 10, 2006
• First Posted (Estimate): March 14, 2006

Study Record Updates

• Last Update Posted (Estimate): December 13, 2012
• Last Update Submitted That Met QC Criteria: December 12, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: carotid, stenting, angioplasty
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carotid Artery Diseases
• Other Study ID Numbers: 05-716