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NCT06276413 Clinical Trial

REgistRy BRAnch goRE EndopRosthEsis

Aortic Dissection Clinical Trial

— REBRA  

Official title:
Registry on Gore Branch Endoprosthesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06276413
Other study ID # REBRA
Secondary ID REBRA
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2030

Study information
Verified date February 2024
Source University Hospital Padova
Contact Michele Antonello, PhD
Phone 0498212636
Email michele.antonello.1@unipd.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Description:

This is a multicenter, non-sponsored, physician-initiated multicenter registry on patients treated with the Gore thoracic branched endoprosthesis. Inclusion of centers is on a voluntary basis; each participating center includes consecutive patients treated with this device.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date December 31, 2030
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies Exclusion Criteria: - less than 18 years - allergy to endograft components - patients receiving other types of arch endografts

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy Vascular and Endovascular Clinic - Padova University Padova

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary early mortality mortality related to the intervention within 30 days 30 days
Primary device stability freedom from related mortality, reintervention, type 1a endoleak during follow-up 5 years
Primary 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 early major adverse events stroke, spinal cord ischemia, vascular complications, cardiac complications, respiratory insufficiency, early reintervention, acute kidney injury 30 days
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