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Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

NCT06658730 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-05-12

No results posted yet for this study

Summary

An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w/AC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.

Conditions

  • Vascular Disease
  • Dissection
  • Dissection Aortic Aneurysm
  • Dissection of Aorta
  • Aneurysm Thoracic
  • Aneurysm Dissecting
  • Transection Aorta
  • Intramural Hematoma

Interventions

DEVICE

Endovascular

TEVAR - thoracic endovascular aortic repair

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Ali Azizzadeh, M.D. · Cedars-Sinai Medical Center

  • Timothy Resch · Univ. of CPH - Denmark

  • Kazuo Shimamura · Osaka University Hospital - Japan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2038-08-31
Completion
2038-08-31
FDA Device
Yes

Countries

  • United States
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06658730 on ClinicalTrials.gov