CAPTURE 2 Post-Marketing Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Composite of death, stroke, and MI (DSMI) [at 30 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Informed Consent for data collection.
-
Intent to use the RX ACCULINK and RX ACCUNET to treat carotid artery disease.
Exclusion Criteria:
none.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abbott Vascular | Santa Clara | California | United States | 95054 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05-716