Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • triple-branched stent graft

    Procedure/Surgery

    a triple-branched stent graft for aortic arch repairement during surgery

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Triple-branched stent graft groupExperimental treatment 1 intervention
Group B: Aortic arch replacement with frozen elephant trunkActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mortality within 30days post-operation

Mortality within 30days post-operation

Time frame
30 days

Secondary outcomes

1

Aortic dissection-related death occurred within 12 months after surgery

Aortic dissection-related death occurred within 12 months after surgery

Time frame
12 month
2

Thrombosis of the false lumen of the arch and proximal descending aorta

Thrombosis of the false lumen of the arch and proximal descending aorta

Time frame
12 month
3

Technical success

Successful insertion, successful positioning, and patency of the lumen were used as indicators

Time frame
12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Medical University

Lead sponsor

Source ClinicalTrials.gov
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