CAPTURE 2 Registry
Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events
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Status:
Ongoing. Currently recruiting patients, with 1987 patients enrolled as of October 2007. Study began March 2006 with an expected completion in December 2007.
Purpose:
To provide an ongoing post-market surveillance mechanism to document clinical outcomes, and provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. Will also evaluate the adequacy of Guidant’s physician training program.
Interventions:
Stent, carotid
Intravascular procedure to maintain carotid artery patency
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Year Started:
2006
Design:
Interventional, treatment, non-randomized, open label, historical control, mulit-center, single group assignment, prospective, safety/efficacy registry.
Inclusion Criteria
Intent to use the RX ACCULINK and RX ACCUNET to treat carotid artery disease.
Patient Involvement:
CAPTURE 2 is a descriptive post-approval registry that will collect data on any rare or unanticipated events that may occur among the patients enrolled.
Primary Outcome:
Composite of death, stroke, and MI (DSMI) from 31-365 days.
Secondary Outcome:
Composite of death, stroke, and MI (DSMI) from 0-365 days.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 1/19/2009
Reviewed on: 07/16/2009.
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