RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-19
Study Completion:2038-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06658730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
  2. 2. Patient has been or is intended to be treated with an eligible registry device.\*
  3. 3. Patient is age ≥ 18 years at time of informed consent signature.
  4. * 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.
  1. 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. 2. Patient with exclusion criteria required by local law.
  3. 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.
  4. * 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).

Contacts and Locations

Study Contact

Ashley Hoedt, MS
CONTACT
+1 928-864-3987
ahoedt@wlgore.com
Megan Warner
CONTACT
480-651-4922
mrwarner@wlgore.com

Principal Investigator

Ali Azizzadeh, M.D.
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Timothy Resch
PRINCIPAL_INVESTIGATOR
Univ. of CPH - Denmark
Kazuo Shimamura
PRINCIPAL_INVESTIGATOR
Osaka University Hospital - Japan

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
Duke University
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: W.L.Gore & Associates

  • Ali Azizzadeh, M.D., PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center
  • Timothy Resch, PRINCIPAL_INVESTIGATOR, Univ. of CPH - Denmark
  • Kazuo Shimamura, PRINCIPAL_INVESTIGATOR, Osaka University Hospital - Japan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-19
Study Completion Date2038-08

Study Record Updates

Study Start Date2025-06-19
Study Completion Date2038-08

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Vascular Disease
  • Dissection
  • Dissection Aortic Aneurysm
  • Dissection of Aorta
  • Aneurysm Thoracic
  • Aneurysm Dissecting
  • Transection Aorta
  • Intramural Hematoma