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

Launched by XUANWU HOSPITAL, BEIJING · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called cold laser plaque ablation, which aims to improve blood flow in the legs for people suffering from serious arterial disease. The trial is looking at whether this method is safe and effective for patients who have narrowing or blockages in their leg arteries, which can cause pain and other problems. The study is currently recruiting participants aged 18 to 85 who have symptoms of lower extremity arterial disease and significant blockages in their leg arteries.

If you decide to participate, you'll need to attend follow-up appointments for six months to track your progress. It's important to know that certain health conditions or recent surgeries may prevent you from joining the trial, so eligibility will be carefully assessed. This study offers a chance to receive a promising treatment and contribute to medical research that could help many others with similar conditions.

Gender

ALL

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.