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Recruiting NCT05054985

Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

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Trial Parameters

Condition Thoracoabdominal Aortic Aneurysms
Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 73
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2021-11-12
Completion 2025-12-31
Interventions
Multi-Branched Thoracoabdominal Stent Graft System

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Brief Summary

Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.

Eligibility Criteria

Inclusion Criteria: 1. 18 years old ≤ age ≤ 80 years old; 2. Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions; 1. Maximum diameter of thoracoabdominal aortic aneurysm\>50mm; 2. The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year; 3. anatomical criteria 1. The proximal anchoring region (aorta or implanted graft) was 17\~36 mm in diameter and ≥25 mm in length; 2. Distal anchoring region (aorta or implanted graft): If the distal anchoring region is in the iliac artery, the anchoring region has a diameter range of 7\~25 mm and a length of ≥15 mm; If the distal anchoring area is in the abdominal aorta, the diameter of the anchoring area ranges from 12\~36mm and the length≥ 20mm; 3. The diameter of the vessel anchoring area of the visceral branch ranges from 6\~13 mm and the len

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