The goal of this prospective, multicenter, randomized controlled clinical trial is to evaluate the safety and efficacy of the WeFlow-EndoSeal™ vAorta Vascular Plug System combined with thoracic endovascular aortic repair (TEVAR) in patients diagnosed with Stanford type B aortic dissection. The main questions it aims to answer are:
Does WeFlow-EndoSeal™ combined with TEVAR provide superior therapeutic efficacy versus standard TEVAR alone for Stanford type B aortic dissection? Does the combined intervention maintain a comparable safety profile relative to standard TEVAR alone? Researchers will compare the test arm (WeFlow-EndoSeal™ Aorta Vascular Plug System plus TEVAR) with the control arm (standard TEVAR alone), with subjects randomized at a 1:1 ratio, to see if the add-on device enhances treatment outcomes without elevating safety risks.
Participants will:
Be randomly assigned to either the test arm or the control arm with equal probability, free from subjective influence of investigators or participants Undergo the corresponding standardized endovascular procedure per their group allocation Complete protocol-specified clinical follow-ups and imaging assessments for efficacy and safety evaluation
Patients aged 18 to 80 years old.
Patients are diagnosed with subacute or chronic Stanford Type B aortic dissection and are scheduled to undergo TEVAR.
Upon imaging evaluation, The the maximum diameter of the false lumen landing zone where the vascular plug is intended to be deployed shall be in the descending thoracic aorta is ≤ ■■ mm..
Patients have suitable access conditions evaluated by imaging, allowing the steerable catheter delivery systems to enter the false lumen via the iliac artery, infrarenal aorta, or at the level of the renal artery tear.
Presence of persistent malperfusion of visceral arterial branches caused by dissection.
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Infectious aortic disease, Takayasu's arteritis, Marfan syndrome (or other connective tissue diseases).
Acute systemic infection.
Parallel
WeFlow-EndoSeal™ Aorta Vascular Plug System
DeviceWeFlow-EndoSeal™ Aorta Vascular Plug System
Thoracic Endovascular Aortic Repair（TEVAR）
Procedure/SurgeryThoracic Endovascular Aortic Repair（TEVAR）
The 12-month Clinical Success Rate
Incidence of freedom from major adverse events within 30 days postoperatively.
Freedom from all-cause death, aortic rupture, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe lower extremity ischemia or necrosis, and paraplegia within 30 days postoperatively.
Immediate Technical Success Rate in the Test Group
Immediate technical success is defined as successful delivery of the Aorta Vascular Plug to the intended position, accurate positioning and successful deployment, with the delivery sheath safely withdrawn outside the body, and no conversion to open surgery.
Thrombosis Status of the False Lumen in the Descending Thoracic Aorta
Compare CTA results obtained preoperatively and at 30 days, 6 months, 12 months, and 24-60 months postoperatively to assess the thrombosis status of the false lumen in the descending thoracic aorta (no thrombosis / partial thrombosis / complete thrombosis).
Change in the Maximum Diameter of the Descending Thoracic Aorta
Compare the CTA results obtained preoperatively and at 30 days, 6 months, 12 months, and 24-60 months postoperatively to assess the change in the maximum diameter of the descending thoracic aorta.
Change in Volume in the Descending Thoracic Aorta
Compare CTA results obtained preoperatively and at 30 days, 6 months, 12 months, and 24-60 months postoperatively to assess the change in true lumen, false lumen and total volume above the celiac trunk in the descending thoracic aorta.
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