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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RX ACCULINK, RX ACCUNET Embolic Protection System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of death, stroke, and MI (DSMI) | at 30 days |
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Inclusion Criteria:
Exclusion Criteria:
none.
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Open-ended enrollment at approximately 400 clinical sites in the United States.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Vascular | Santa Clara | California | 95054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21349464 | Derived | 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. | |
| 20576398 |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Derived |
| 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |