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TBE Zone 0/1 PMS in Japan

6. juli 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

75

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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).

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Aortabrudd av behandlingslesjonen
Tidsramme: 60 måneder
Ruptur i det behandlede segmentet av fartøyet (f.eks. Aorta eller gren) bekreftet med direkte observasjon eller CT / CTA -skanning.
60 måneder
Alvorlig paraplegia
Tidsramme: 60 måneder
Paraplegia sekundær til ryggmargs -iskemi rapportert som en alvorlig bivirkning fra steder.
60 måneder
Alvorlig paraparese
Tidsramme: 60 måneder
Paraparesis sekundær til ryggmargs iskemi rapportert som en alvorlig bivirkning fra steder.
60 måneder
Nyresvikt som krever dialyse
Tidsramme: 60 måneder
Nyresvikt rapportert som en alvorlig bivirkning av nettsteder og bekreftet å kreve dialyse.
60 måneder
Alvorlig enhetsrelatert iskemi
Tidsramme: 60 måneder
Iskemi rapportert av nettsteder som en alvorlig bivirkning som er bestemt til å være relatert til enheten.
60 måneder
Distal enhetsrelatert tromboembolsk alvorlig bivirkning som krever intervensjon eller kirurgi
Tidsramme: 60 måneder
Enhetsrelaterte iskemiske bivirkninger rapportert av nettsteder som alvorlige bivirkninger som krevde bypass-kirurgi, kirurgiske inngrep eller amputasjon, eller som resulterte i død.
60 måneder
Alvorlig hjerteinfarkt
Tidsramme: 60 måneder
Hjerteinfarkt rapportert som en alvorlig bivirkning av nettstedene.
60 måneder
Alvorlig laryngeal eller frenisk nerveskade
Tidsramme: 60 måneder
Nerveskadehendelser rapportert av nettstedene som alvorlige bivirkninger som krevde retretetting.
60 måneder
Alvorlig hjertesvikt/hypotensjon
Tidsramme: 60 måneder
Hjertesvikt eller hypotensjon rapportert som alvorlige bivirkninger av nettstedene.
60 måneder
Device Technical Success at the Initial Endovascular Procedure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

W.L.Gore & Associates

Samarbeidspartnere

CMIC Co, Ltd. Japan

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2035

Studiet fullført (Antatt)

1. september 2035

Datoer for studieregistrering

Først innsendt

19. juni 2026

Først innsendt som oppfylte QC-kriteriene

6. juli 2026

Først lagt ut (Faktiske)

9. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • JPS 25-10

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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