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

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT06658730

Acronym / sponsor ID

TGR 23-02TA / TGR 23-02TA

Conditions

Vascular Disease, Dissection, Dissection Aortic Aneurysm, Dissection of Aorta, Aneurysm Thoracic, Aneurysm Dissecting

Keywords

Endovascular, CTAG, Post-market Registry, Observational, Multi-regional, Real world data, Together Registry, Gore Together Registry

Study type

Observational

Recruitment status

Recruiting

Enrolment

1,500 participants (estimated)

Lead sponsor

W.L.Gore & AssociatesIndustry (pharma, biotech, devices)

Study start

19 Jun 2025 (actual)

Primary completion

Aug 2038 (estimated)

Study completion

Aug 2038 (estimated)

First posted

26 Oct 2024 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

10 Years

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Deployment Technical Success

   Time frame: Index Procedure

   * 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.

2. Lesion-related Mortality

   Time frame: From time of index procedure through 10 years of follow-up

   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.

3. Lesion Rupture (treated area)

   Time frame: Through 10 years post-procedure

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

4. Lesion Enlargement (treated area)

   Time frame: Through 10 years post-procedure

   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.

5. Endoleaks

   Time frame: Through 10 years post-procedure

   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

6. Device Migration

   Time frame: Through 10 years post-procedure

   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.

7. Loss of aortic / branch patency

   Time frame: Through 10 years post-procedure

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

8. Stroke (All, Serious, Non-Serious)

   Time frame: Through 10 years post-procedure

   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

9. Paraplegia (within 30 days of index procedure)

   Time frame: Within 30 days of index procedure

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

10. Paraparesis (within 30 days of index procedure)

    Time frame: 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

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

    Time frame: 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

12. Renal function deterioration

    Time frame: Within 30 days of index procedure

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

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

    Time frame: Through 10 years post-procedure

    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

14. Reintervention

    Time frame: Through 10 years post-procedure

    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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
• Derived from this study: PubMed 42729155Yamanouchi D, Khashram M, Gable D, Milner R, Yeung KK, Resch TA, Bockler D, Delaney C, Azizzadeh A, Shimamura K, Qasabian R, Han S, Feito Y, Trimarchi S. Real-world data on aortic endografts: Gore Together aortic registry protocol. Front Cardiovasc Med. 2026 Aug 28;13:1803528. doi: 10.3389/fcvm.2026.1803528. eCollection 2026.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

37 sites in 10 countries: see every site and its status.