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

NCT ID: NCT06211127

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-12-31

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.

Conditions

Arterial Disease of Legs; Atherosclerosis of Artery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cold laser plaque ablation

Intervention Type: DEVICE

Patients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery.

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.

Group Type: ACTIVE_COMPARATOR

The excimer laser

Intervention Type: DEVICE

Patients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery.

Interventions

Cold laser plaque ablation

Patients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery.

Intervention Type: DEVICE

The excimer laser

Patients were randomly divided into two groups. After being included in the two groups, different laser equipment was used to revascularize the lower limbs. The patients' revascularization status was evaluated through regular follow-up after surgery.

Intervention Type: DEVICE

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lianrui Guo, M.D.

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lianrui Guo, M.D.

Role: CONTACT

lianruiguo@sina.com

+8613671009746

Jianming Guo, M.D.

Role: CONTACT

guojianming@aliyun.com

13146369562

Facility Contacts

Lianrui Guo, MD

Role: primary

Xixiang Gao

Role: backup

vascsurgeon@163.com

+8613581674309

Other Identifiers

ZKRG-PAD-202304

Identifier Type: -

Identifier Source: org_study_id