Active — Not RecruitingNot Applicable

the Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration

China120 participantsStarted 2021-07-25

Plain-language summary

A prospective, multi-center, single-group target value method to evaluate the safety and effectiveness of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in situ fenestration technology in the treatment of aortic dissection involving the aortic arch

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 (to be selected if all of the following criteria are met)： * 18 years old ≤age≤80 years old, no gender limitation; * Diagnosis of aortic dissection and reconstruction of the left subclavian artery; * The main branches and branches of the aortic arch at the lesion site have sufficient anatomical basis: * The diameter range of the near-end anchoring zone of the main body of the fixed mechanism: 21-46mm; * The length of the anchor zone near the principal part of the tunnel is ≥10mm; * The length of the anchor zone of the branching vessel of the convex target is ≥15mm; * The diameter range of the distal anchoring zone of the target branching vessel is 5-18mm. * The patient has adequate surgical access vessels; * Patients who understand the purpose of the study, voluntarily participate in and sign informed consent, and are willing to follow up. Exclusion Criteria (If one of the following criteria is met, it will not be selected)： * The patient is pregnant or breastfeeding; * The patient had a history of cardiac surgery (congenital heart disease surgery, heart valve surgery, coronary heart disease surgery, thoracic aortic surgery, etc.), which would affect the implementation of this TEVAR surgery; * The patient has been implanted or planned to be implanted with left ventricular auxiliary pump, interventional valve and other instruments, or is planning to undergo coronary intervention surgery, and aortic dissection is expected to affect the function of…

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 end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery

Timeframe: Within 30 days after procedure

Primary efficacy endpoint of the Aorta Arch Stent Graft System: treatment success at 12 months after surgery

Timeframe: 12 months after procedure

Primary endpoint of the Endovascular Needle System: Immediate surgical success rate of the Endovascular Needle System

Timeframe: intraoperative

Trial details

NCT IDNCT05126446

SponsorLifetech Scientific (Shenzhen) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-30

View on ClinicalTrials.gov More Aortic Dissection trials