Cold laser treatment for blocked arteries in the legs

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

This study is testing if cold laser treatment can help people with blocked arteries in their legs feel better compared to a different laser treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06211127 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of cold laser plaque ablation for treating lower limb arterial stenosis and occlusive lesions. It is a prospective, multi-center, randomized controlled study involving four medical centers and aims to enroll 110 patients. Participants will receive either cold laser plaque ablation or treatment with an excimer laser system, with outcomes assessed over a six-month follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with symptomatic lower extremity arterial disease and significant arterial stenosis or occlusion.

Not a fit: Patients with prior vascular procedures in the target limb or those with lesions in artificial or bypass vessels may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for patients suffering from severe leg artery blockages.

How similar studies have performed: While the approach of using cold laser plaque ablation is relatively novel, similar studies on laser treatments for arterial disease have shown promising results.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Lianrui Guo, M.D.

Conditions: Arterial Disease of Legs, Atherosclerosis of Artery, cold laser plaque ablation, lower limb arterial stenosis, occlusive lesions, Atherectomy