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

NCT06658730 | Recruiting DMC FDA Device

• 1 other identifier: TGR 23-02TA
• Study Type: observational
• Target: 1,500
• Locations: 7 countries
• Sites: 10

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (14)

• Deployment Technical Success

  * Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system. * The absence of any additional corrective procedure related to the device, procedure, or withdrawal of the delivery system. Events will not include interventions at the access site(s), lumbar drains to address spinal cord ischemia, or additional interventions to address non-treatment areas.

  Index Procedure

• Lesion-related Mortality

  Death meeting at least one of the following characteristics: * Death within 30 days of the index procedure or following conversion to open repair. * Death within 30 days following a complication from a secondary procedure associated with the index lesion or registry device. * Any death where the treated disease / index lesion or registry device caused or significantly contributed to the death, including lesion-rupture, aortic-related complications, disease progression involving the index lesion.

  From time of index procedure through 10 years of follow-up

• Lesion Rupture (treated area)

  Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.

  Through 10 years post-procedure

• Lesion Enlargement (treated area)

  An increase in maximum vessel (e.g., aorta or treated branch) diameter of \> 5 mm in the region encompassed by the initial lesion as compared to baseline using orthogonal (i.e., perpendicular to the centerline) measurements on CT / CTA scans.

  Through 10 years post-procedure

• Endoleaks

  Perfusion of a treated lesion via: * Type I endoleak is defined as a sealing failure at one of the attachment zones of the graft to the vessel wall, whereby arterial flow perfuses the treated lesion via a perigraft channel: * Type Ia: Proximal aortic attachment zone * Type Ib: Distal aortic attachment zone * Type Ic: Distal attachment zone for branch component * Type II: Retrograde flow from native aortic branch arteries * Type III endoleak: Component disconnection or fabric disruption resulting in arterial flow into the perigraft space * Type IIIa: Attachment of aortic components (aortic-aortic) * Type IIIb: Fabric tear or disruption * Type IIIc: Attachment of aortic component-side-branch or side-branch-side-branch * Type IV: Late endoleak due to flow through porous fabric * Type V/Endotension: Aneurysm sac enlargement \> 5 mm with no imaging evidence of an endoleak * Indeterminate: Endoleak is identified, but source cannot be ascertained

  Through 10 years post-procedure

• Device Migration

  Longitudinal movement of all or part of the device for a distance ≥ 10 mm, as confirmed by CTA scan, relative to anatomical landmarks and device positioning at the first post-operative CTA scan.

  Through 10 years post-procedure

• Loss of aortic / branch patency

  No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.

  Through 10 years post-procedure

• Stroke (All, Serious, Non-Serious)

  Stroke is the acute onset of symptoms consistent with focal or multifocal Central Nervous System (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that: * Persists for \> 24 hours or until death -or- * Symptoms lasting \< 24 hours, with pathology or neuroimaging confirmation of CNS infarction

  Through 10 years post-procedure

• Paraplegia (within 30 days of index procedure)

  New onset spinal cord injury rendering a subject non-ambulatory within 30 days of the index procedure

  Within 30 days of index procedure

• Paraparesis (within 30 days of index procedure)

  New onset spinal cord injury causing a minor motor deficit of the lower extremities within 30 days of the index procedure

  Within 30 days of index procedure

• New onset renal failure (within 30 days of index procedure)

  New onset sustained renal failure identified within 30 days of the index procedure, combined with requiring dialysis for \> 4 weeks

  Within 30 days of index procedure

• Renal function deterioration

  New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.

  Within 30 days of index procedure

• Device integrity events (e.g., fracture, kinking, compression)

  Defined as any of the following: * Wire fractures, including stents, hooks, or barbs * Stent kinking: Narrowing of the stent graft associated with demonstrable angulation in any of the stent components, with demonstrable flow * Disruption/tears in the graft component of the stent graft Stent compression or invagination: Transient or permanent stent-graft collapse following complete device deployment, resulting in an overall reduction in the vessel luminal diameter

  Through 10 years post-procedure

• Reintervention

  Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure. This may include surgical or interventional treatment for endoleaks, access site(s) complications, disease progression (including interventions to address issues related to non-treated area of the index lesion, such as bare stent implantation to address bowel ischemia associated with aortic dissection), spinal drains for Spinal Cord Injury (SCI) management, or conversion to open surgery.

  Through 10 years post-procedure

Secondary Outcomes (6)

• Access-related complications

  Intra-operatively

• Transient Ischemic Attack (TIA)

  Through 10 years post-procedure

• New Dissection

  Through 10 years post-procedure

• False Lumen Status - treated segment

  Through 10 years post-procedure

• False Lumen Status - untreated segment

  Through 10 years post-procedure

Other Outcomes (1)

• Health Economic and Quality of Life Data Analysis

  Through 10 years post-procedure

Study Arms (2)

Aneurysm/Other Isolated Lesion

Device: Endovascular

Dissection

Device: Endovascular

Interventions

Endovascular DEVICE

TEVAR - thoracic endovascular aortic repair

Aneurysm/Other Isolated Lesion; Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (10)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Rigshospitalet

Copenhagen, DK-2100, Denmark

RECRUITING

Centre Hospitalier Universitaire Strasbourg

Strasbourg, 67000, France

RECRUITING

Universitatsmedizin Frankfurt

Frankfurt, Germany

RECRUITING

Regensburg University Hospital

Regensburg, D-93053, Germany

RECRUITING

Laiko General Hospital of Athens

Athens, 11527, Greece

RECRUITING

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

RECRUITING

Uppsala University

Uppsala, SE-751 85, Sweden

RECRUITING

MeSH Terms

Conditions

Vascular Diseases; Aortic Dissection; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Dissection, Blood Vessel; Aneurysm; Acute Aortic Syndrome; Aortic Diseases; Aortic Aneurysm

Study Officials

• Ali Azizzadeh, M.D.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Timothy Resch

  Univ. of CPH - Denmark

  PRINCIPAL INVESTIGATOR

• Kazuo Shimamura

  Osaka University Hospital - Japan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Hoedt, MS

CONTACT

+1 928-864-3987; ahoedt@wlgore.com

Megan Warner

CONTACT

480-651-4922; mrwarner@wlgore.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 26, 2024
• Study Start: June 19, 2025
• Primary Completion (Estimated): August 1, 2038
• Study Completion (Estimated): August 1, 2038
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); DE (2); ES (1); DK (1); SE (1); GR (1); FR (1)