Using a special stent graft for surgery on acute aortic dissection

Safety and Effectiveness of a Triple-branched Stent Graft for Arch Repair During Open Aute Debakey Type I Dissection Surgery - a Randomized Controlled Multicenter Clinical Trial

This study is testing a special type of stent graft during surgery to see if it can help patients with a serious tear in their aorta recover better after treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: Fujian Medical University (Academic / other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06492980 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of a triple-branched stent graft during surgery for patients with acute type I aortic dissection. The study is a prospective, multicenter, randomized controlled trial that aims to improve surgical outcomes for this life-threatening condition. Acute aortic dissection is characterized by a tear in the aorta, leading to serious complications, and the trial focuses on patients who require arch repair. Participants will be monitored for their recovery and the performance of the stent graft during and after the procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 65 who have been diagnosed with acute type I aortic dissection and require arch repair.

Not a fit: Patients with anatomical variations or secondary dissection due to prior aortic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve surgical outcomes and survival rates for patients with acute type I aortic dissection.

How similar studies have performed: While there have been studies on surgical interventions for aortic dissection, the specific use of a triple-branched stent graft in this context is a novel approach.

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 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.
4. Severe infectious lesions that are not controlled;
5. Patients who need to receive other concomitant treatments, such as severe hypertension, chronic obstructive pulmonary disease, coronary heart disease, chronic kidney disease and other serious underlying lesions that require long-term treatment;
6. Patients with other life-threatening lesions, such as advanced malignant tumors, and whose expected survival time is less than one year;
7. Patients with other lesions in the heart and aorta (patients with other heart diseases that require concurrent heart surgery, such as coronary heart disease, mitral valve disease, tricuspid valve disease, etc.), who are not suitable for stent interventional treatment, such as peripheral vascular disease and blood disease;
8. Subjects who have participated in other drug or device clinical trials and have not reached the primary study endpoint; and pregnant women.

Where this trial is running

Fuzhou, Fujian

• Department of Cardiovascular Surgery — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Liang-wan Chen, M.D Ph.D

Conditions Acute Aortic Dissection