NCT06211127

Safety and Efficacy of Cold Laser Plaque Ablation for Lower Limb Arterial Stenosis and Occlusive Lesions

Assessment the Safety and Efficacy of Cold Laser Plaque Ablation for Lower Limb Arterial Stenosis and Occlusive Lesions: A Prospective, Multicenter, Randomized Controlled Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-center, randomized controlled study, which evaluates the effectiveness and safety of cold laser plaque ablation for lower limb arterial stenosis and occlusive lesions from intermittent claudication to chronic threatening limb ischemia.

Detailed description

This study is a prospective, multi-center, randomized controlled study. This study will be conducted at four centers and is expected to enroll 110 patients. And we will evaluate the effectiveness and safety of cold laser plaque ablation compared to excimer laser system for lower limb arterial stenosis and occlusive lesions.

Conditions

• Arterial Disease of Legs
• Atherosclerosis of Artery

Interventions

Type	Name	Description
DEVICE	Cold laser plaque ablation	Patients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery.
DEVICE	The excimer laser	Patients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery.

Timeline

• Start date: 2023-10-16
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2024-01-18
• Last updated: 2024-01-18

Locations

1 site across 1 country: China