Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Eligibility criteria
Qualifiers
Patients who are aged 18 to 80 years inclusive；
Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be anchored in the Z0 zone;
Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 30 mm;
Disqualifiers
Patients either with ruptured or infected aneurysms;
Patients with aortic dissection;
Patients with general or local infections that may increase the risk of endovascular graft infection;
Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or affect stent patency;
Trial design
Treatments tested in this trial
- Concave Supra-arch Branched Stent-Graft System
Treatment groups
103 Participants
are divided into 1 treatment groupLocations
17China
Fuwai Hospital, Chinese Academy of Medical Sciences Beijing China
Second Xiangya Hospital of Central South University Changsha China
West China Hospital, Sichuan University Chengdu China
The First Affiliated Hospital of Fujian Medical University Fuzhou China
Sponsors and collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
Lead sponsor
Second Xiangya Hospital of Central South University
Collaborator
Source ClinicalTrials.gov