Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch D
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
| Condition(s) | Aortic Arch Aneurysm, Penetrating Aortic Ulcer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: 1. Patients who are aged 18 to 80 years inclusive； 2. 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; 3. Anatomical criteria, including: 1. Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery); 2. 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; 3. The diameter of the anchored area of supra-arch branch vessels (innominate artery, left common carotid artery, left subclavian artery) is between 5-18 mm, distal anchorage length is greater than or equal to 15 mm; 4. Distance between |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. |
| Locations | Beijing, China; Changsha, China; Chengdu, China; Fuzhou, China; Fuzhou, China; Hanzhou, China (+11 more sites) |
| Start date | 2024-05-30 |
| NCT ID | NCT06520774 |
| Official listing | https://clinicaltrials.gov/study/NCT06520774 |