Clinical trial NCT06658730: Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
Official title: Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vascular Disease
Dissection
Dissection Aortic Aneurysm
Dissection of Aorta
Aneurysm Thoracic
Aneurysm Dissecting
Transection Aorta
Intramural Hematoma
Keywords: Endovascular
CTAG
Post-market Registry
Observational
Multi-regional
Real world data
Together Registry
Gore Together Registry
Gore Together Aortic Registry
Conformable Thoracic Stent Graft
TGR 23-02TA
TGR23-02TA
GORE TAG
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target registry population is patients who are treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL at participating sites. This includes initial procedures and reinterventions (regardless of original intervention).

Brief 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 criteria: Inclusion Criteria:

1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
2. Patient has been or is intended to be treated with an eligible registry device.\*
3. 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, consent prior to the time of discharge for the index procedure is acceptable.

Exclusion Criteria:

1. 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.
2. Patient with exclusion criteria required by local law.
3. 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.

   * The term "study" does not apply to other observational registries or quality improvement projects. Collection of Registry Device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions).

Primary outcomes:
measure: Deployment Technical Success
timeFrame: Index Procedure
measure: Lesion-related Mortality
timeFrame: From time of index procedure through 10 years of follow-up
measure: Lesion Rupture (treated area)
timeFrame: Through 10 years post-procedure
measure: Lesion Enlargement (treated area)
timeFrame: Through 10 years post-procedure
measure: Endoleaks
timeFrame: Through 10 years post-procedure
measure: Device Migration
timeFrame: Through 10 years post-procedure
measure: Loss of aortic / branch patency
timeFrame: Through 10 years post-procedure
measure: Stroke (All, Serious, Non-Serious)
timeFrame: Through 10 years post-procedure
measure: Paraplegia (within 30 days of index procedure)
timeFrame: Within 30 days of index procedure
measure: Paraparesis (within 30 days of index procedure)
timeFrame: Within 30 days of index procedure
measure: New onset renal failure (within 30 days of index procedure)
timeFrame: Within 30 days of index procedure
measure: Renal function deterioration
timeFrame: Within 30 days of index procedure
measure: Device integrity events (e.g., fracture, kinking, compression)
timeFrame: Through 10 years post-procedure
measure: Reintervention
timeFrame: Through 10 years post-procedure
Secondary outcomes:
measure: Access-related complications
timeFrame: Intra-operatively
measure: Transient Ischemic Attack (TIA)
timeFrame: Through 10 years post-procedure
measure: New Dissection
timeFrame: Through 10 years post-procedure
measure: False Lumen Status - treated segment
timeFrame: Through 10 years post-procedure
measure: False Lumen Status - untreated segment
timeFrame: Through 10 years post-procedure
measure: False Lumen Perfusion
timeFrame: Through 10 years post-procedure
Other outcomes:
measure: Health Economic and Quality of Life Data Analysis
timeFrame: Through 10 years post-procedure
Locations:
Study officials:
name: Ali Azizzadeh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: