NCT05670171

Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease.

Assessment the Safety and Efficacy of Debulking Atherectomy Versus Stent Angioplasty for Limb Ischaemia of Diabetic Lower Limb Atherosclerosis-occlusive Disease: A Multicenter, Randomized, Controlled Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In order to assessment the safety and efficacy of debulking atherectomy versus stent angioplasty for limb ischaemia of diabetic lower limb atherosclerosis-occlusive disease, we intend to conduct a prospective, multicenter, randomized controlled, non-inferiority trial. The main surgical methods included stent angioplasty group (Nickel-titanium self-expanding bare stent) and debulking atherectomy group (Excimer laser atherectomy combined with drug-coated balloon angioplasty). The sample size was 244 patients, and the patients were followed up at 30 days, 180 days, and 365 days after operation.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
PROCEDURE	Debulking Atherectomy	Excimer laser atherectomy combined with drug-coated balloon angioplasty
PROCEDURE	Stent Angioplasty	Nickel-titanium self-expanding bare stent

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-01-04
• Last updated: 2023-01-04

Locations

10 sites across 1 country: China