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

NCT06211127 | Unknown DMC

• 1 other identifier: ZKRG-PAD-202304
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Disease of Legs; Atherosclerosis of Artery

Keywords

cold laser plaque ablation; lower limb arterial stenosis; occlusive lesions; Atherectomy

Outcome Measures

Primary Outcomes (1)

• residual diameter stenosis

  Reduction from baseline in residual diameter stenosis (measured in percent), prior to any adjunctive therapy, achieved by the laser catheter, as assessed quantitatively by the core laboratory based upon the procedure angiograms.

  1 month, 6 months after surgery

Secondary Outcomes (9)

• Secondary effectiveness evaluating indicator:1）Primary patency rate

  1 month, 6 months after surgery

• Secondary effectiveness evaluating indicator:2）Revascularization rate of target vessels

  1 month, 6 months after surgery

• Secondary effectiveness evaluating indicator:3）Rutherford grade

  1 month, 6 months after surgery

• Secondary effectiveness evaluating indicator:4）Ankle-brachial index

  1 month, 6 months after surgery

• Secondary effectiveness evaluating indicator:5)Instrument performance evaluation

  1 month

Study Arms (2)

Cold laser plaque ablation group

EXPERIMENTAL

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.

Device: Cold laser plaque ablation

The excimer laser group

ACTIVE COMPARATOR

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.

Device: The excimer laser

Interventions

Cold laser plaque ablation 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.

Cold laser plaque ablation group

The excimer laser 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General selection criteria
• Age between 18 and 85, gender is not limited;
• Patients with symptomatic lower extremity arteriosclerosis disease (LEAD), Rutherford grade 2 to 5;
• The stenosis of lower extremity arteries is greater than 70% or occlusion;
• The subject is able and willing to comply with all requirements, including 6-month follow-up and evaluation, voluntary participation and informed consent.
• The internal diameter of the reference vessel proximal to the target lesion is greater than 1.8mm;
• The stenosis of target lesion is greater than 70%;

You may not qualify if:

• The target lesion is located in the artificial vascular or autologous venous vascular bypass;
• 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;
• Intent to use other atherectomy device in the same procedure;
• Flow-limiting dissection within, proximal or distal to the target lesion;
• Evidence or history of aneurysm in the target vessel， intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months;
• Uncorrected coagulation abnormalities (platelet count ≤ 75\*109/ L or INR≥2.0), bleeding constitution, and history of heparin-induced thrombocytopenia (HIT);
• Any thrombolytic therapy was performed within 2 weeks before surgery;
• History of severe trauma, fracture, major surgery, or parenchymal organ biopsy within 2 weeks before surgery;
• Known allergy to contrast agents or perioperative drugs;
• Anticoagulation, antiplatelet or thrombolytic therapy is prohibited;
• Pregnant or lactating women;
• Subjects participating in other clinical trials of drugs or medical devices;
• Other circumstances assessed by the investigator as inappropriate to participate in the trial.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Henan Provincial People's Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Study Officials

• Lianrui Guo, M.D.

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Lianrui Guo, M.D.

CONTACT

+8613671009746; lianruiguo@sina.com

Jianming Guo, M.D.

CONTACT

13146369562; guojianming@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 18, 2024
• Study Start: October 16, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)