Menu
Recruiting NCT06658730

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

— Observational Vascular Disease Dissection Dissection Aortic Aneurysm Dissection of Aorta

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endovascular.
Who it may be relevant to
Registry conditions: Vascular Disease, Dissection, Dissection Aortic Aneurysm, Dissection of Aorta. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Denmark, France, Germany, Greece +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Endovascular
    TEVAR - thoracic endovascular aortic repair

Primary outcome measures

  • Deployment Technical Success [Time frame: Index Procedure]
  • Lesion-related Mortality [Time frame: From time of index procedure through 10 years of follow-up]
  • Lesion Rupture (treated area) [Time frame: Through 10 years post-procedure]
  • Lesion Enlargement (treated area) [Time frame: Through 10 years post-procedure]
  • Endoleaks [Time frame: Through 10 years post-procedure]
  • Device Migration [Time frame: Through 10 years post-procedure]
  • Loss of aortic / branch patency [Time frame: Through 10 years post-procedure]
  • Stroke (All, Serious, Non-Serious) [Time frame: Through 10 years post-procedure]
  • Paraplegia (within 30 days of index procedure) [Time frame: Within 30 days of index procedure]
  • Paraparesis (within 30 days of index procedure) [Time frame: Within 30 days of index procedure]
Secondary outcome measures (6)
  • Access-related complications [Time frame: Intra-operatively]
  • Transient Ischemic Attack (TIA) [Time frame: Through 10 years post-procedure]
  • New Dissection [Time frame: Through 10 years post-procedure]
  • False Lumen Status - treated segment [Time frame: Through 10 years post-procedure]
  • False Lumen Status - untreated segment [Time frame: Through 10 years post-procedure]
  • False Lumen Perfusion [Time frame: Through 10 years post-procedure]

Eligibility criteria

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.
  • 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.

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.
  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 24 centers
  • University of Arizona — Tucson
  • University of Southern California — Los Angeles
  • Cedars-Sinai Medical Center — Los Angeles
  • Leland Stanford Junior University — Stanford
  • MedStar Health, MedStar Washington Hospital Center — Washington D.C.
  • University of Florida - Gainesville — Gainesville
  • University of South Florida — Tampa
  • Augusta University — Augusta
  • … and 16 more centers
Germany · 4 centers
  • Universitatsmedizin Frankfurt — Frankfurt
  • Regensburg University Hospital — Regensburg
  • Regensburg University Hospital — Regensburg
  • Universitatsklinikum Ulm — Ulm
Italy · 2 centers
  • AORN S.Anna e S. Sebastiano — Caserta
  • IRCCS Policlinico di Milano — Milan
Denmark · 1 center
  • Rigshospitalet — Copenhagen
France · 1 center
  • Centre Hospitalier Universitaire Strasbourg — Strasbourg
Greece · 1 center
  • Laiko General Hospital of Athens — Athens
Saudi Arabia · 1 center
  • King Faisal Specialist Hospital and Research Center — Ryadh
Spain · 1 center
  • Hospital Universitari de Bellvitge — Barcelona
Sweden · 1 center
  • Uppsala University — Uppsala

Identifiers

NCT: NCT06658730 · TGR 23-02TA · TGR 23-02TA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗