Clinical trial NCT06211127: Safety and Efficacy of Cold Laser Plaque Ablation for Lower Limb Arterial Stenosis and Occlusive Lesions
Official title: Assessment the Safety and Efficacy of Cold Laser Plaque Ablation for Lower Limb Arterial Stenosis and Occlusive Lesions: A Prospective, Multicenter, Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arterial Disease of Legs
Atherosclerosis of Artery
Keywords: cold laser plaque ablation
lower limb arterial stenosis
occlusive lesions
Atherectomy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital Xi'an Jiaotong University
name: Henan Provincial People's Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2024-01-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: residual diameter stenosis
timeFrame: 1 month, 6 months after surgery
Secondary outcomes:
measure: Secondary effectiveness evaluating indicator:1）Primary patency rate
timeFrame: 1 month, 6 months after surgery
measure: Secondary effectiveness evaluating indicator:2）Revascularization rate of target vessels
timeFrame: 1 month, 6 months after surgery
measure: Secondary effectiveness evaluating indicator:3）Rutherford grade
timeFrame: 1 month, 6 months after surgery
measure: Secondary effectiveness evaluating indicator:4）Ankle-brachial index
timeFrame: 1 month, 6 months after surgery
measure: Secondary effectiveness evaluating indicator:5)Instrument performance evaluation
timeFrame: 1 month
measure: safety evaluating indicator:1) Major Adverse Event (MAE)
timeFrame: 1 month, 6 months after surgery
measure: safety evaluating indicator:2）Device-associated composite endpoint (Do CE)
timeFrame: 1 month
measure: safety evaluating indicator:3）Adverse events / Serious adverse events (AE / SAE)
timeFrame: 1 month, 6 months after surgery
measure: safety evaluating indicator:4）Incidence of device defects
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Lianrui Guo, M.D.
role: STUDY_CHAIR
References: