REgistRy BRAnch goRE EndopRosthEsis

Not yet recruiting

• Conditions: Aortic Dissection; Aortic Aneurysm, Thoracic

• Registration Number: NCT06276413
• Lead Sponsor: University Hospital Padova

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Study Start: 2024-03-01
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
device stability	5 years	freedom from related mortality, reintervention, type 1a endoleak during follow-up
technical success	30 days	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
early mortality	30 days	mortality related to the intervention within 30 days

Secondary Outcome Measures

Name	Time	Method
early major adverse events	30 days	stroke, spinal cord ischemia, vascular complications, cardiac complications, respiratory insufficiency, early reintervention, acute kidney injury

Trial Locations

Locations (1)

Vascular and Endovascular Clinic - Padova University; 🇮🇹 Padova, Italy