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: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
⁃ General selection criteria
• Age between 18 and 85, gender is not limited;
• Patients with symptomatic lower extremity arteriosclerosis disease (LEAD), Rutherford grade 2 to 5;
• The stenosis of lower extremity arteries is greater than 70% or occlusion;
• The subject is able and willing to comply with all requirements, including 6-month follow-up and evaluation, voluntary participation and informed consent.
⁃ Intraoperative contrast inclusion criteria
• The internal diameter of the reference vessel proximal to the target lesion is greater than 1.8mm;
• The stenosis of target lesion is greater than 70%;
Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Lianrui Guo, M.D.
lianruiguo@sina.com
+8613671009746
Backup
Jianming Guo, M.D.
guojianming@aliyun.com
13146369562
Time Frame
Start Date:2023-10-16
Estimated Completion Date:2024-12-31
Participants
Target number of participants:110
Treatments
Experimental: Cold laser plaque ablation group
The disposable cold laser plaque ablation catheter (hereinafter referred to as the ablation catheter) is used in conjunction with the cold laser plaque ablation System), which is suitable for the treatment of arteriosclerosis stenosis and occlusive lesions of the lower limbs.
Active_comparator: The excimer laser group
Excimer laser uses 308nm wavelength excimer laser to conduct atherosclerotic plaques through the intertwined optical fibers in the catheter, using three action mechanisms of photothermal energy, photochemical energy and acoustic mechanical energy.