RecruitingNot Applicable

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

United States, Denmark, France1,500 participantsStarted 2025-06-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
✕. Patient with exclusion criteria required by local law.
✕. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study\* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

What they're measuring

Deployment Technical Success

Timeframe: Index Procedure

Lesion-related Mortality

Timeframe: From time of index procedure through 10 years of follow-up

Lesion Rupture (treated area)

Timeframe: Through 10 years post-procedure

Lesion Enlargement (treated area)

Timeframe: Through 10 years post-procedure

Endoleaks

Timeframe: Through 10 years post-procedure

Device Migration

Timeframe: Through 10 years post-procedure

Loss of aortic / branch patency

Timeframe: Through 10 years post-procedure

Stroke (All, Serious, Non-Serious)

Timeframe: Through 10 years post-procedure

Trial details

NCT IDNCT06658730

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2038-08

Contact for this trial

Ashley Hoedt, MS

+1 928-864-3987 ahoedt@wlgore.com

View on ClinicalTrials.gov More Vascular Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
✕. Patient with exclusion criteria required by local law.
✕. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study\* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

What they're measuring

Deployment Technical Success

Timeframe: Index Procedure

Lesion-related Mortality

Timeframe: From time of index procedure through 10 years of follow-up

Lesion Rupture (treated area)

Timeframe: Through 10 years post-procedure

Lesion Enlargement (treated area)

Timeframe: Through 10 years post-procedure

Endoleaks

Timeframe: Through 10 years post-procedure

Device Migration

Timeframe: Through 10 years post-procedure

Loss of aortic / branch patency

Timeframe: Through 10 years post-procedure

Stroke (All, Serious, Non-Serious)

Timeframe: Through 10 years post-procedure