Clinical trial NCT00302237: CAPTURE 2 Post-Marketing Registry
Official title: Second Phase of "Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Disease
Keywords: carotid, stenting, angioplasty
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-03-14
Enrollment: 6426
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Open-ended enrollment at approximately 400 clinical sites in the United States.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite of death, stroke, and MI (DSMI)
timeFrame: at 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
affiliation: Executive Committee Member
name: William Gray, M.D.
role: STUDY_DIRECTOR
affiliation: Executive Committee Member
name: Jaysinghe Yadav, M.D.
role: STUDY_DIRECTOR
affiliation: Executive Committee Member
name: Richard Atkinson, M.D.
role: STUDY_DIRECTOR
affiliation: Executive Committee
name: Ronald Fairman, M.D.
role: STUDY_DIRECTOR
affiliation: Executive Committee Member
name: Mark Wholey, M.D.
role: STUDY_DIRECTOR
affiliation: Executive Committee Member
name: Rod Raabe, M.D.
role: STUDY_DIRECTOR
affiliation: Executive Committee Member
name: Richard Green, M.D.
role: STUDY_DIRECTOR
affiliation: Executive Committee Member
name: Nick Hopkins, M.D.
role: STUDY_DIRECTOR
affiliation: Executive Committee Member
name: Stan Barnwell, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.