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Updated: Jul 18, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
The CAPTURE registry: results of carotid stenting with embolic protection in the post approval setting
William A Gray1, Jay S Yadav, Patrick Verta
1Center for Interventional Vascular Therapies, Columbia University, 161 Fort Washington Avenue 5th Floor, New York, NY 10032, USA. wgray@crf.org
Insights
Carotid stenting demonstrates comparable safety and effectiveness to traditional surgery for high-risk patients. Post-approval studies confirm that training programs adequately prepare physicians for this less invasive procedure.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Pivotal studies established carotid stenting with embolic protection as a less invasive option for high-risk patients.
- This report evaluates carotid stenting outcomes after broader adoption beyond highly selected centers.
Purpose of the Study:
- Assess carotid stenting safety by physicians with varied experience levels.
- Evaluate the effectiveness of physician training programs.
- Identify rare or unexpected device-related complications.
Main Methods:
- Prospective, multi-center registry (Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events - CAPTURE).
- Enrolled 3,500 patients treated by 353 physicians at 144 sites.
- Primary endpoint: composite of death, stroke, or myocardial infarction within 30 days.
Main Results:
- The 30-day primary event rate was 6.3%, with no significant difference across operator experience levels (P=0.31).
- Outcomes were consistent across physician specialties after adjusting for case mix.
- No unanticipated device-related adverse events were reported.
Conclusions:
- Carotid stenting outcomes in community practice compare favorably to pivotal trial data.
- Post-approval training effectively prepares physicians of varying experience and specialties.
- Carotid stenting is a safe and effective option in real-world settings.
Background:
Pivotal study data examining carotid stenting with embolic protection as a less invasive alternative to endarterectomy for high surgical risk patients have been acquired under controlled conditions with highly selected physicians and hospitals. This report examines outcomes of carotid stenting post-approval after diffusion of this technology to a broader cross-section of physicians and hospitals.
Methods:
The Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) is a prospective, multi-center registry to assess two important aspects of the post-IDE experience: the safety of carotid stenting by physicians with varying levels of experience as a measure of the adequacy of physician training, and the identification of rare/unexpected device-related complications. The primary endpoint was a composite of death, any stroke, or myocardial infarction within 30 days post-procedure.
Results:
3,500 patients were enrolled by 353 physicians at 144 sites. The 30-day primary endpoint event rate was 6.3% (95% CI: 5.5-7.1%) and did not differ among the three operator experience levels (5.3%, 6.0%, and 7.4%; P = 0.31) from most to least experienced, respectively. There were no differences in outcomes among physician specialties when adjusted for case mix. There were no unanticipated device related adverse events.
Conclusions:
The results of the CAPTURE study compare favorably to those achieved in the predicate pivotal investigations, and suggest that the post-approval transfer of this new therapy to the community practice setting via carotid stent training programs is effective in preparing physicians with varying experience levels and specialty training backgrounds.
