Aortic Arch Single Branch Covered Stent System: to Evaluate the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
Study summary
The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Age between 18 and 80 years, gender unrestricted.
* Patients are diagnosed with Stanford Type B aortic dissection and need revascularization of the left subclavian artery.
* Anatomical criteria:
* The diameter range of the proximal aortic landing zone is 20-42 mm.
* The length of the proximal aortic landing zone (the distance from the posterior edge of the left common carotid artery orifice to the first intimal tear) is ≥15 mm.
* The distance between the left common carotid artery and the left subclavian artery is ≥5 mm.
* The length of the left subclavian artery landing zone is ≥25 mm, and the diameter range of the landing zone is 5-15 mm.
* Suitable access to the femoral artery, iliac artery, and upper limb artery.
* Patients understand the purpose of the study, volunteer to participate, and are willing to complete follow - up visits as required by the protocol.
Exclusion Criteria:
* Previously undergone endovascular interventional treatment involving the aortic arch, or having a history of aortic surgical repair surgery, which affects the implantation and evaluation of the single branched covered stent system of the aortic arch.
* Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area pose challenges. Such conditions may easily prevent covered stents from adhering to the vessel wall or affect stent patency.
* Infectious aortic diseases, giant cell arteritis, Marfan syndrome (or other hereditary connective tissue diseases).
* Patients with systemic or local infections that may increase the risk of infection of the endovascular graft.
* Patients who have received abdominal aortic surgical or endovascular interventional surgery within the past 3 months.
* Patients who have had a stroke attack (excluding transient ischemic attack, TIA) or myocardial infarction within the past 3 months.
* Patients known to be allergic to contrast agents, stent materials, and delivery device materials (referring to nitinol, Dacron, PTFE, nylon polymer materials).
* Patients known to have contraindications to anticoagulant and antiplatelet drugs.
* Patients intolerant to general anesthesia.
* Patients with severe abnormalities in liver, kidney, and cardiac function before the operation \[Subjects with a serum creatinine level exceeding 150 μmol/L; Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Subjects with serum total bilirubin (STB) exceeding 2 times the upper limit of the normal value; Subjects with a left ventricular ejection fraction lower than 50% as indicated by echocardiography.\].
* Patients whose expected lifespan is shorter than 1 year.
* Female patients who are planning to conceive, are currently pregnant, or are breastfeeding.
* Patients whom, in the researcher's judgment, are not appropriate candidates for endovascular treatment.
* Patients who have been involved in other clinical studies and have not withdrawn from or exited the respective study groups within the three months preceding the screening period of this present study.
Primary outcome measure(s)
Incidence rate for freedom from major adverse events (MAE) within 30 days postoperatively — pre-discharge up to 14 days and 30 days post-surgery Major adverse events refer to the occurrences of all-cause death, myocardial infarction, renal failure, liver failure, respiratory failure, paraplegia, ischemic stroke, intestinal necrosis. Among them, renal failure means that it leads to persistent dialysis, kidney transplantation, or other fatal outcomes. Respiratory failure means that it leads to a significantly prolonged intubation time, tracheotomy, deterioration of lung function, or other fatal outcomes. Intestinal necrosis refers to intestinal ischemia that requires intestinal resection or leads to other fatal outcomes.
Procedural success rate of aortic dissection treatment 12 months postoperatively — intraoperative and 12 months postoperatively The composite endpoints include immediate technical success post-procedure and, at the 12-month CTA reexamination, the absence of displacement of the main aortic and branch stents, no type I or III endoleaks, patency of the branch stents, and no secondary surgical interventions during follow-up.
Trial sites (1)
Facility
City
Region
Status
Second Xiangya Hospital of Central South University
Changsha
China
Recruiting
More Lifetech Scientific (Shenzhen) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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