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Recruiting NCT06492980

A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery

Trial Parameters

Condition Acute Aortic Dissection
Sponsor Fujian Medical University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 20 Years
Max Age 65 Years
Start Date 2023-10-27
Completion 2024-10-10
Interventions
triple-branched stent graft

Brief Summary

Prospective, multicenter, randomized controlled clinical trial plan to evaluate the effectiveness and safety of intraoperative stent system in the treatment of acute type I aortic dissection

Eligibility Criteria

Inclusion Criteria: 1. Patients with acute type I aortic dissection who need arch repair; 2. Aged ≥20 years and ≤65 years; 3. Acute phase, with onset within 14 days before surgery; 4. Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to accept follow-up. Exclusion Criteria: 1. The presence of anatomical variations, such as aortic arch malformation, aortic coarctation; common origin of the innominate artery and the left common carotid artery, aberrant right subclavian artery, abnormal origin of the left conical artery, stenosis or distortion of the branch arteries; and the diameter of the aortic arch and branch artery diameters do not match the specifications of the test device; 2. Dissection is secondary to a history of aortic treatment, Marfan syndrome, etc. 3. Aortic lesions and branch artery lesions caused by acute type I aortic dissection, including aortic pre-rupture, branch artery rupture, branch arte

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