Not Yet RecruitingNot Applicable

GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

United States125 participantsStarted 2026-03

Plain-language summary

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

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 the TBE Device in Zone 0 or Zone 1.
✓. 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 defined follow-up visits.
✕. 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 study enrollment. Subjects cannot be enrolled in another Gore study.

What they're measuring

Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure

Timeframe: Index Endovascular Procedure Only

Device Technical Success (index procedure only)

Timeframe: Index Endovascular Procedure Only

Lesion-related mortality

Timeframe: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure

Disabling Stroke

Timeframe: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure

Permanent Paraplegia (within 30-days)

Timeframe: Within 30 days of index endovascular procedure

Permanent Paraparesis (within 30-days)

Timeframe: Within 30 days of index endovascular procedure

New onset renal failure (within 30-days) requiring on-going dialysis

Timeframe: Within 30 days of index endovascular procedure

Trial details

NCT IDNCT07166133

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07

Contact for this trial

DeAnne Hart

800-437-8181 tbe25-03@wlgore.com

View on ClinicalTrials.gov More Aortic Arch Dissection trials

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 the TBE Device in Zone 0 or Zone 1.
✓. 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 defined follow-up visits.
✕. 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 study enrollment. Subjects cannot be enrolled in another Gore study.

What they're measuring

Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure

Timeframe: Index Endovascular Procedure Only

Device Technical Success (index procedure only)

Timeframe: Index Endovascular Procedure Only

Lesion-related mortality

Timeframe: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure

Disabling Stroke

Timeframe: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure

Permanent Paraplegia (within 30-days)

Timeframe: Within 30 days of index endovascular procedure

Permanent Paraparesis (within 30-days)

Timeframe: Within 30 days of index endovascular procedure

New onset renal failure (within 30-days) requiring on-going dialysis

Timeframe: Within 30 days of index endovascular procedure