Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases (NCT06520774) | Clinical Trial Compass
RecruitingNot Applicable
Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
China103 participantsStarted 2024-05-30
Plain-language 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
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✓. Anatomical criteria, including:
✓. 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;
✓. 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;
✓. Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
✓. Have a suitable iliac, femoral, and superior arch arterial access;
Exclusion criteria
✕. 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;
✕
What they're measuring
1
Incidence of composite endpoints
Timeframe: within 30 days post-surgery
2
The clinical treatment success rate within 12 months
Timeframe: pre-discharge (up to 14 days) and 12 months postoperatively
. 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;
✕. Previous endovascular intervention involving the aortic arch;
✕. Underwent open or endovascular surgery for abdominal aorta within the past 3 months;
✕. Patients with a history of stroke within the past 3 months (excluding TIA);
✕. Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;