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NCT05659641
The Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection(BROAD)
Conditions: Aortic Dissection, Aneurysm, Dissecting, Aneurysm, Vascular Diseases, Cardiovascular Diseases
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 259
Sponsor: Permed Biomedical Engineering Co., Ltd
Location: China
Summary
The purpose of the study was to evaluate the safety and efficacy of a branched type intraoperative stent system for the treatment of Stanford type A aortic dissection
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 and ≤ 75 years, male or female;Stanford type A aortic dissection subjects with involvement of the descending arch aorta;Subjects treated with stent pictorial procedures as judged appropriate by the investigator;Subjects or their legal surrogates were able to understand the purpose of the study, had adequate compliance to the clinical study protocol, and voluntarily signed the informed consent form.Exclusion Criteria:Subjects with aortic dissections confined to the ascending and / or archSubjects with a left common carotid artery branch vessel diameter < 5 mm or > 16 mm (not applicable to subjects enrolled with a single branch structure)Subjects with a left subclavian artery branch vessel diameter < 7 mm or > 16 mmSubjects with aortic dissection with severe malperfusion syndrome preoperatively (e.g., subjects presenting with coma, paraplegia, need for dialysis, gastrointestinal necrosis or limb necrosis due to ischemia, etc.)Subjects with vertebral artery variantsSubjects with infectious aortic dissectionsSubjects with acute systemic infection, severe infection and associated sepsis, shock or multiple organ failureSubjects unable to tolerate anaesthesia and cardiopulmonary bypassSubjects who had undergone open surgical procedures of the cardiocerebral vasculature within 90 days prior to surgerySubjects with history of active bleeding, coagulopathy or refusal of blood transfusionSubjects known to be allergic to materials such as contrast agents, nitinol alloys, coated artificial blood vesselsSubjects with a life expectancy of less than 12 months (other than disease due to aortic dissection)Subjects being enrolled in other clinical trialsPregnant and lactating women, and subjects with a recent pregnancy preparationSubjects with poor compliance other conditions that the investigator considers inappropriate for participation in the clinical trial.
Source: ClinicalTrials.gov (NCT05659641). StuddyBuddy aggregates publicly available trial information.