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Sponsored by: |
Abbott Vascular |
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Information provided by: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT00302237 |
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.
Condition | Intervention | Phase |
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Carotid Artery Disease |
Device: RX ACCULINK, RX ACCUNET Embolic Protection System |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Second Phase of "Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events" |
Estimated Enrollment: | 10000 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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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.
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
none.
Contact: Sharon Gordon | 408.845.0699 | sharon.gordon@av.abbott.com |
Contact: Lugene Keene | 1-800-633-3375 |
United States, California | |
Abbott Vascular | Recruiting |
Santa Clara, California, United States, 95054 | |
Contact: Sharon Gordon 800-633-3375 sharon.gordon@av.abbott.com | |
Contact: Lugene Keene 408 845-0522 lugene.keene@av.abbott.com |
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 |
Responsible Party: | Abbott Vascular ( Matt Kiely ) |
Study ID Numbers: | 05-716 |
Study First Received: | March 10, 2006 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00302237 |
Health Authority: | United States: Institutional Review Board |
carotid, stenting, angioplasty |
Vascular Diseases Central Nervous System Diseases Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |