RecruitingNot Applicable

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

China73 participantsStarted 2021-11-12

Plain-language summary

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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 years old ≤ age ≤ 80 years old;
. 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;
. Maximum diameter of thoracoabdominal aortic aneurysm\>50mm;
. The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;
. anatomical criteria
. The proximal anchoring region (aorta or implanted graft) was 17\~36 mm in diameter and ≥25 mm in length;
. 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;
. The diameter of the vessel anchoring area of the visceral branch ranges from 6\~13 mm and the length ≥15 mm;

Exclusion criteria

. Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary safety endpoint: The incidence of Major Adverse events (MAE) within 30 days after procedure.

Timeframe: Within 30 days after procedure

Primary efficacy endpoint: Success rate of thoracoabdominal aortic aneurysm treatment 12 months after procedure.

Timeframe: 12 months after procedure.

Trial details

NCT IDNCT05054985

SponsorLifetech Scientific (Shenzhen) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Wei Guo, Professor

13910758706 pla301dml@vip.sina.com

View on ClinicalTrials.gov More Thoracoabdominal Aortic Aneurysms trials