NCT06276413

Brief Summary

Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
56mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Mar 2024Dec 2030

First Submitted

Initial submission to the registry

February 16, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

February 16, 2024

Last Update Submit

February 16, 2024

Conditions

Aortic Aneurysm, ThoracicAortic Dissection

Keywords

endograft

Outcome Measures

Primary Outcomes (3)

  • early mortality

    mortality related to the intervention within 30 days

    30 days

  • device stability

    freedom from related mortality, reintervention, type 1a endoleak during follow-up

    5 years

  • technical success

    succesful deployment of all endograft components at the intended site with complete aneurysm exclusion, without surgical conversion, type Ia/III endoleak, kink, stenosis, graft occlusion

    30 days

Secondary Outcomes (1)

  • early major adverse events

    30 days

Interventions

GORE TAG Thoracic Branch EndoprosthesisDEVICE

deployment of the GORE TAG Thoracic Branch Endoprosthesis fro thoraci aorta pathologies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients treated with the Gore TAG thoracic branched endograft in the participating centers

You may qualify if:

  • patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies

You may not qualify if:

  • less than 18 years
  • allergy to endograft components
  • patients receiving other types of arch endografts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vascular and Endovascular Clinic - Padova University

Padua, 35020, Italy

Location

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicAortic Dissection

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDissection, Blood VesselAcute Aortic Syndrome

Central Study Contacts

Michele Antonello, PhD

CONTACT

0498212636michele.antonello.1@unipd.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 26, 2024

Study Start

March 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

IT(1)