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TBE Zone 0/1 PMS in Japan

6 juli 2026 uppdaterad av: W.L.Gore & Associates

GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Market Surveillance in Japan

The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0/1 lesion on post-marketing usage conditions.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

75

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients who attempted implant of TBE in Zone 0/1 during the enrollment period for each indication (including patients in whom TBE is not placed in Zone 0/1 area).

Beskrivning

Inclusion Criteria:

Those who are suitable for use of TBE according to the Japan package insert. [Reference: Purpose of Use or Effects of TBE at the time of launch] The GORE® TAG® Thoracic Branch Endoprosthesis is intended for use in patients with the following diseases of the aortic arch and descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to a single aortic arch target branch vessel.

  • Thoracic aortic aneurysm
  • Traumatic transection
  • Complicated Stanford type A (after surgical repair) and B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy

The GORE® TAG® Thoracic Branch Endoprosthesis may be used in combination with designated stent grafts with validated efficacy and safety.

Exclusion Criteria:

N/A

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Aneurysm cohort

Thoracic Aortic Aneurysm: 50 patients (including at least 5 surgically repaired patients who have the proximal landing zone that is a surgical graft)

Before 5 surgically repaired patients are enrolled if the other 45 patients are confirmed to be enrolled, enrollment of the other patients will be considered complete at that point, and only surgically repaired patients will continue to be enrolled.
Enhet: Gore® TAG® Thoracic Aortic Branch Stent Graft System
Patients who attempted implant of TBE in Zone 0/1 during the enrollment period for each indication (including patients in whom TBE is not placed in Zone 0/1 area).
Dissection and Traumatic Transection cohort
  • Complicated chronic Stanford type B aortic dissection (including dissecting aneurysm): at least 10 patients, and enrollment will be considered complete when the enrollment of 15 patients is confirmed.
  • Complicated Stanford type A (after surgical repair) aortic dissection: at least 10 patients, and enrollment will be considered complete when the enrollment of 15 patients is confirmed.

If, during the enrollment period for the dissection and traumatic transection cohort, an attempt is made to place TBE in patients with complicated acute Stanford type B aortic dissection or in patients with traumatic thoracic aortic transection, those patients will also be enrolled in the dissection and traumatic transection cohort.
Enhet: Gore® TAG® Thoracic Aortic Branch Stent Graft System
Patients who attempted implant of TBE in Zone 0/1 during the enrollment period for each indication (including patients in whom TBE is not placed in Zone 0/1 area).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Aortasbrott i behandlingsskadan
Tidsram: 60 månader
Brott i det behandlade segmentet av kärlet (t.ex. aorta eller gren) verifierad med direkt observation eller CT / CTA -skanning.
60 månader
Allvarlig paraplegi
Tidsram: 60 månader
Paraplegia sekundär till ryggmärgsischemi rapporterade som en allvarlig biverkning från platser.
60 månader
Allvarlig paraparesis
Tidsram: 60 månader
Paraparesis sekundär till ryggmärgsischemi rapporterade som en allvarlig biverkning från platser.
60 månader
Njursvikt som kräver dialys
Tidsram: 60 månader
Njurfel rapporterade som en allvarlig biverkning av platser och bekräftas att kräva dialys.
60 månader
Allvarlig enhetsrelaterad ischemi
Tidsram: 60 månader
Ischemi rapporterade av platser som en allvarlig biverkning fastställda att vara relaterade till enheten.
60 månader
Distal enhetsrelaterad tromboembolisk allvarlig negativ händelse som kräver ingripande eller operation
Tidsram: 60 månader
Enhetsrelaterade ischemiska biverkningar rapporterade av platser som allvarliga biverkningar som krävde förbikopplingskirurgi, kirurgiska ingrepp eller amputation, eller som resulterade i döden.
60 månader
Allvarlig hjärtinfarkt
Tidsram: 60 månader
Hjärtinfarkt rapporterade som en allvarlig biverkning av platserna.
60 månader
Allvarlig laryngeal eller frenisk nervskada
Tidsram: 60 månader
Händelser på nervskador rapporterade av platserna som allvarliga biverkningar som krävde återförsäljning.
60 månader
Allvarlig hjärtsvikt/hypotension
Tidsram: 60 månader
Hjärtsvikt eller hypotension rapporterade som allvarliga biverkningar av platserna.
60 månader
Device Technical Success at the Initial Endovascular Procedure
Tidsram: TBE Initial Implant Procedure

All of the following must be met.

  • Successful access and delivery
  • Patency of devices
  • The absence of unanticipated additional procedure related to the device, the TBE implant procedure, or withdrawal of the delivery system
TBE Initial Implant Procedure
Lesion-related Mortality and All-cause Death
Tidsram: 60 Months

Lesion-related Mortality that meet any of the following criteria:

  • All deaths within 30 days after the revascularization procedure or the TBE implant procedure during the initial hospitalization or secondary procedures resulting from the treated lesion or endovascular treatment (e.g., procedures for retrograde dissection, loss of patency, loss of device integrity, endoleak, migration, aortic dilation, aneurysm rupture)
  • All deaths related to the treated lesion or device (e.g., aneurysm rupture, retrograde dissection resulting in fatal cardiac tamponade) Not applicable if there is evidence to support no relationship to the lesion.
60 Months
Disabling Stroke
Tidsram: 60 Months

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
60 Months
Additional Unanticipated Post-procedural Reintervention
Tidsram: 60 Months

Additional unanticipated surgical procedure or endovascular procedure related to TBE, TBE implant procedure, or revascularization procedure for TBE implant after the revascularization procedure or TBE implant procedure.

Anticipated or unanticipated status will be determined at the discretion of the investigator.

Surgical procedures include conversion to thoracotomy. Endovascular procedures include stent graft implants for endoleaks, aortic enlargement and loss of patency, and procedures on the branch to improve or restore patency.

Events will not include access site(s) complications, interventions to address issues related to non-treated area of the index lesion, such as bare stent implant to address bowel ischemia associated with aortic dissection.
60 Months
Serious New Dissection
Tidsram: 60 Months
New events of aortic dissection reported as serious adverse events by sites.
60 Months
Aortic Enlargement in the Region Encompassed by the Initial Lesion
Tidsram: 60 Months
An increase of 5 mm or more in arterial diameter at the treated area compared to images taken at the first follow-up after the TBE implant procedure.
60 Months
Endoleak
Tidsram: 60 Months

Serious adverse events reported or confirmed by imaging by the sites.

The definitions of each type of endoleaks are as follows:

  • Type I endoleak is defined as a sealing failure at one of the attachment sites of the graft to the vessel wall. Arterial flow therefore leaks alongside the graft and into the perigraft space.
  • Type Ia: Proximal leak
  • Type Ib: Distal leak
  • Type Ic: Inadequate seal at distal landing zone for side branch component
  • Type II endoleak is defined as retrograde flow from branch arteries arising from the treated segment of the aorta.
  • Type III endoleak
  • Type IIIA endoleak : Attachment of aortic components (aortic-aortic).
  • Type IIIB endoleak : Fabric tear or disruption.
  • Type IIIC endoleak : Attachment of aortic component-side-branch or side-branch-side-branch
  • Type IV endoleak is defined as flow through porous fabric.
  • Indeterminate : Endoleak detected with unknown source.
60 Months
Loss of Device Integrity
Tidsram: 60 Months

Defined as any of the following:

  • Wire fractures identified in the sealing row stents of the aortic component (AC), branch component (SB) or aortic extender (AE).
  • 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
  • Transient (compression) or permanent stent-graft collapse (invagination) following complete device deployment, resulting in an overall reduction in the aortic or branch vessel luminal diameter.
  • If the device loses function due to other malformations
60 Months
Loss of Aortic or Aortic Branch Patency
Tidsram: 60 Months
No flow or contrast detected through the implanted aortic or side branch devices or distal CTAG devices after the TBE implant procedure.
60 Months
Migration
Tidsram: 60 Months
Longitudinal movement of all or part of the device for a distance ≥10 mm, as confirmed by imaging, relative to anatomical landmarks and device positioning at the first post-operative imaging.
60 Months
False Lumen Perfusion through the Primary Entry Tear (Dissection Patients only)
Tidsram: 60 Months
Confirm the presence or absence of blood flow from a proximal aortic source through the primary entry tear into the aortic false lumen, based on imaging.
60 Months
Extension of a Dissection (Proximally or Distally) (Dissection Patients only)
Tidsram: 60 Months
Among the aortic dissections reported by sites as serious adverse events, those in which proximal or distal progression of the lesion from the TBE implant procedure was confirmed on imaging.
60 Months
False Lumen Status in Treated and Untreated Segments (Dissection Patients only)
Tidsram: 60 Months

The thrombosis state of the false lumen at the treated and untreated segments at the TBE implant procedure is confirmed using the following three stages.

  • Patent is defined as flow present throughout the aortic false lumen in the absence of evidence of thrombus.
  • Partially thrombosed false lumen is defined as clot within the aortic false lumen that has a residual patent flow channel.
  • Thrombosed false lumen is defined as complete thrombosis of the aortic false lumen.
60 Months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

W.L.Gore & Associates

Samarbetspartners

CMIC Co, Ltd. Japan

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2035

Avslutad studie (Beräknad)

1 september 2035

Studieregistreringsdatum

Först inskickad

19 juni 2026

Först inskickad som uppfyllde QC-kriterierna

6 juli 2026

Första postat (Faktisk)

9 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • JPS 25-10

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

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