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

Launched by FUJIAN MEDICAL UNIVERSITY · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called a triple-branched stent graft to see how well it works for patients with a specific heart condition known as acute type I aortic dissection. This condition occurs when there is a tear in the inner layer of the aorta, which is the large blood vessel that carries blood from the heart to the rest of the body. The trial aims to evaluate the safety and effectiveness of this stent during surgery for patients who need repair of the aortic arch.

To be eligible for the trial, participants must be between 20 and 65 years old and have experienced the dissection within the last 14 days. They should also be able to understand the trial, give their consent, and agree to follow-up check-ups. Unfortunately, not everyone can join; for example, those with certain heart or blood vessel conditions or serious other health issues may not be eligible. If someone is accepted into the trial, they can expect to undergo surgery using this new stent, with careful monitoring to ensure their safety throughout the process.

Gender

ALL

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.