A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery
ConditionAcute Aortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorFujian Medical University
About this trial
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
Qualifiers
Patients with acute type I aortic dissection who need arch repair;
Aged ≥20 years and ≤65 years;
Acute phase, with onset within 14 days before surgery;
Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to accept follow-up.
Disqualifiers
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;
Dissection is secondary to a history of aortic treatment, Marfan syndrome, etc.
Aortic lesions and branch artery lesions caused by acute type I aortic dissection, including aortic pre-rupture, branch artery rupture, branch artery occlusion, and severe ischemic complications caused by poor organ perfusion, such as myocardial ischemia, stroke (ischemic brain injury), paraplegia (spinal artery ischemia), mesenteric artery ischemia, renal artery dysplasia, etc.
Severe infectious lesions that are not controlled;
Trial design
Treatments tested in this trial
- triple-branched stent graft
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov