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

Capital Medical University

Status: Enrolling

Conditions: Arterial Disease of Legs; Atherosclerosis of Artery

Treatments: Device: The excimer laser; Device: Cold laser plaque ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06211127

ZKRG-PAD-202304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

General selection criteria

1. Age between 18 and 85, gender is not limited;
2. Patients with symptomatic lower extremity arteriosclerosis disease (LEAD), Rutherford grade 2 to 5;
3. The stenosis of lower extremity arteries is greater than 70% or occlusion;
4. 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

1. The internal diameter of the reference vessel proximal to the target lesion is greater than 1.8mm;
2. The stenosis of target lesion is greater than 70%;

Exclusion criteria

1. The target lesion is located in the artificial vascular or autologous venous vascular bypass;
2. Endovascular or surgical procedure in the target limb performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure;
3. Intent to use other atherectomy device in the same procedure;
4. Flow-limiting dissection within, proximal or distal to the target lesion;
5. Evidence or history of aneurysm in the target vessel， intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
6. Uncorrected coagulation abnormalities (platelet count ≤ 75*109/ L or INR≥2.0), bleeding constitution, and history of heparin-induced thrombocytopenia (HIT);
7. Any thrombolytic therapy was performed within 2 weeks before surgery;
8. History of severe trauma, fracture, major surgery, or parenchymal organ biopsy within 2 weeks before surgery;
9. Known allergy to contrast agents or perioperative drugs;
10. Anticoagulation, antiplatelet or thrombolytic therapy is prohibited;
11. Pregnant or lactating women;
12. Subjects participating in other clinical trials of drugs or medical devices;
13. Other circumstances assessed by the investigator as inappropriate to participate in the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Cold laser plaque ablation group

Experimental group

Description:

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.

Treatment:

Device: Cold laser plaque ablation

The excimer laser group

Active Comparator group

Description:

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.

Treatment:

Device: The excimer laser