Status:
RECRUITING
A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery
Lead Sponsor:
Fujian Medical University
Conditions:
Acute Aortic Dissection
Eligibility:
All Genders
20-65 years
Phase:
NA
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
Detailed Description
Acute aortic dissection is a local rupture in the aortic intima. Blood flows into the middle layer from the rupture, causing the middle layer of the aortic wall to tear along the long axis, tearing th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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;
- Patients with other life-threatening lesions, such as advanced malignant tumors, and whose expected survival time is less than one year;
- 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;
- Subjects who have participated in other drug or device clinical trials and have not reached the primary study endpoint; and pregnant women.
Key Trial Info
Start Date :
October 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06492980
Start Date
October 27 2023
End Date
October 10 2025
Last Update
July 9 2024
Active Locations (1)
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1
Department of Cardiovascular Surgery
Fuzhou, Fujian, China, 350001