NCT05186181

Endovascular Repair With In Situ nEedle feNestration of Left Subclavian Artery to Treat AoRtic Dissection(RISEN STAR):A Multicenter Prospective Trial.

Endovascular Repair of Stanford B-type Thoracic Aortic Dissection With Insufficient Proximal Landing Zone by Left Subclavian Artery in Situ Stent Graft Puncture and Fenestration: A Prospective, Single-arm, Observational Clinical Trial.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 217 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Background: Aortic dissection (AD) is a common emergency in vascular surgery, which seriously threatens human life and health. The rupture of Stanford type B dissection is located in aortic arch and the dissection range is from the descending aorta or involves the abdominal aorta. At present, the endovascular repair of the thoracic aorta (TEVAR) for AD has been widely deployed worldwide and has become the standard surgical procedure for the treatment of AD. However, there is still controversy regarding the Stanford B aortic dissection that involves the left subclavian artery or the stent landing area less than 1.5 cm. Study objective: To evaluate the effectiveness and safety of endovascular repair with in situ needle fenestration of left subclavian artery. Methods: This study intends to enroll 217 patients with Stanford type B aortic dissection who meet the enrollment criteria. The patients will be followed up at 1, 6, 12, and 24 months after endovascular repair, and the CTA images of the thoracic aorta were collected.

Conditions

• Aortic Dissection
• Left Subclavian Artery Occlusion
• Vascular Diseases
• Interventional Therapy

Interventions

Type	Name	Description
BEHAVIORAL	In situ fenestration	Interventional therapy of aortic dissection. In situ needle fenestration of left subclavian artery.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-01-01
• Completion: 2025-12-01
• First posted: 2022-01-11
• Last updated: 2023-02-22

Locations

1 site across 1 country: China