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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.

• Patient has been or is intended to be treated with an eligible registry device.\*

• Patient is age ≥ 18 years at time of informed consent signature.

⁃ The intent to treat a patient with a Gore product must be made prior to soliciting for possible registry participation. If pre-procedure consent is not feasible due to emergent situation, consent prior to the time of discharge for the index procedure is acceptable.

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
North Carolina
Duke University
RECRUITING
Durham
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Ashley Hoedt, MS
ahoedt@wlgore.com
+1 928-864-3987
Backup
Megan Warner
mrwarner@wlgore.com
480-651-4922
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2038-08
Participants
Target number of participants: 1500
Treatments
Aneurysm/Other Isolated Lesion
Dissection
Sponsors
Leads: W.L.Gore & Associates

This content was sourced from clinicaltrials.gov