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

NCT ID: NCT06658730

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-19

Study Completion Date

2038-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aneurysm/Other Isolated Lesion

Endovascular

Intervention Type DEVICE

TEVAR - thoracic endovascular aortic repair

Dissection

Endovascular

Intervention Type DEVICE

TEVAR - thoracic endovascular aortic repair

Interventions

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Endovascular

TEVAR - thoracic endovascular aortic repair

Intervention Type DEVICE

Eligibility Criteria

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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 due to emergent situation, 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.
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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Azizzadeh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Timothy Resch

Role: PRINCIPAL_INVESTIGATOR

Univ. of CPH - Denmark

Kazuo Shimamura

Role: PRINCIPAL_INVESTIGATOR

Osaka University Hospital - Japan

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status RECRUITING

Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Centre Hospitalier Universitaire Strasbourg

Strasbourg, , France

Site Status RECRUITING

Regensburg University Hospital

Regensburg, , Germany

Site Status RECRUITING

Laiko General Hospital of Athens

Athens, , Greece

Site Status RECRUITING

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status RECRUITING

Uppsala University

Uppsala, , Sweden

Site Status RECRUITING

Countries

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United States Denmark France Germany Greece Spain Sweden

Central Contacts

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Ashley Hoedt, MS

Role: CONTACT

+1 928-864-3987

Megan Warner

Role: CONTACT

480-651-4922

Facility Contacts

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Ayda Aliyari

Role: primary

Terri Strickland

Role: primary

Michael Watson

Role: primary

Timothy A Resch, Prof.

Role: primary

+45 35457931

Mette Velloev Petersen, Mrs

Role: backup

+45 3545 6207

Salomé Kuntz, Dr.

Role: primary

Manon Ruhlmann

Role: backup

Fiona Rohlffs, Prof.

Role: primary

Chris Klonaris, Dr.

Role: primary

Antonia Skotsimara

Role: backup

Elena Iborra Ortega, Dr.

Role: primary

0034932706500

Kevin Mani, MD

Role: primary

Clara Clara Rydmyr

Role: backup

+46 0186112394

Other Identifiers

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TGR 23-02TA

Identifier Type: OTHER

Identifier Source: secondary_id

TGR 23-02TA

Identifier Type: -

Identifier Source: org_study_id

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