The CAPTURE Registry: Results of carotid stenting with embolic protection in the post approval setting

William A. Gray, Jay S. Yadav, Patrick Verta, Andrea Scicli, Ronald Fairman, Mark Wholey, L. Nelson Hopkins, Richard Atkinson, Rod Raabe, Stanley Barnwell, Richard Green

Research output: Contribution to journalArticle

172 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)341-348
Number of pages8
JournalCatheterization and Cardiovascular Interventions
Volume69
Issue number3
DOIs
StatePublished - Feb 15 2007

Fingerprint

Registries
Physicians
Equipment and Supplies
Endarterectomy
Diagnosis-Related Groups
Stents
Stroke
Myocardial Infarction
Technology
Safety
Education

Keywords

  • Carotid
  • Outcomes
  • Post-market study
  • Stent
  • Training

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

The CAPTURE Registry : Results of carotid stenting with embolic protection in the post approval setting. / Gray, William A.; Yadav, Jay S.; Verta, Patrick; Scicli, Andrea; Fairman, Ronald; Wholey, Mark; Hopkins, L. Nelson; Atkinson, Richard; Raabe, Rod; Barnwell, Stanley; Green, Richard.

In: Catheterization and Cardiovascular Interventions, Vol. 69, No. 3, 15.02.2007, p. 341-348.

Research output: Contribution to journalArticle

Gray, WA, Yadav, JS, Verta, P, Scicli, A, Fairman, R, Wholey, M, Hopkins, LN, Atkinson, R, Raabe, R, Barnwell, S & Green, R 2007, 'The CAPTURE Registry: Results of carotid stenting with embolic protection in the post approval setting', Catheterization and Cardiovascular Interventions, vol. 69, no. 3, pp. 341-348. https://doi.org/10.1002/ccd.21050
Gray, William A. ; Yadav, Jay S. ; Verta, Patrick ; Scicli, Andrea ; Fairman, Ronald ; Wholey, Mark ; Hopkins, L. Nelson ; Atkinson, Richard ; Raabe, Rod ; Barnwell, Stanley ; Green, Richard. / The CAPTURE Registry : Results of carotid stenting with embolic protection in the post approval setting. In: Catheterization and Cardiovascular Interventions. 2007 ; Vol. 69, No. 3. pp. 341-348.
@article{86fc958111a7432590fb0dd572677223,
title = "The CAPTURE Registry: Results of carotid stenting with embolic protection in the post approval setting",
abstract = "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.",
keywords = "Carotid, Outcomes, Post-market study, Stent, Training",
author = "Gray, {William A.} and Yadav, {Jay S.} and Patrick Verta and Andrea Scicli and Ronald Fairman and Mark Wholey and Hopkins, {L. Nelson} and Richard Atkinson and Rod Raabe and Stanley Barnwell and Richard Green",
year = "2007",
month = "2",
day = "15",
doi = "10.1002/ccd.21050",
language = "English (US)",
volume = "69",
pages = "341--348",
journal = "Catheterization and Cardiovascular Interventions",
issn = "1522-1946",
publisher = "Wiley-Liss Inc.",
number = "3",

}

TY - JOUR

T1 - The CAPTURE Registry

T2 - Results of carotid stenting with embolic protection in the post approval setting

AU - Gray, William A.

AU - Yadav, Jay S.

AU - Verta, Patrick

AU - Scicli, Andrea

AU - Fairman, Ronald

AU - Wholey, Mark

AU - Hopkins, L. Nelson

AU - Atkinson, Richard

AU - Raabe, Rod

AU - Barnwell, Stanley

AU - Green, Richard

PY - 2007/2/15

Y1 - 2007/2/15

N2 - 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.

AB - 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.

KW - Carotid

KW - Outcomes

KW - Post-market study

KW - Stent

KW - Training

UR - http://www.scopus.com/inward/record.url?scp=33847385381&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33847385381&partnerID=8YFLogxK

U2 - 10.1002/ccd.21050

DO - 10.1002/ccd.21050

M3 - Article

C2 - 17171654

AN - SCOPUS:33847385381

VL - 69

SP - 341

EP - 348

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

SN - 1522-1946

IS - 3

ER -