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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerosis of Artery; Arterial Disease of Legs
• Intervention / Treatment: Device: Cold laser plaque ablation; Device: The excimer laser

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianming Guo, M.D.; Phone Number: 13146369562; Email: guojianming@aliyun.com
• Study Contact Backup: Name: Lianrui Guo, M.D.; Phone Number: +8613671009746; Email: lianruiguo@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Lianrui Guo, MD
      • Contact: Xixiang Gao; Phone Number: +8613581674309; Email: vascsurgeon@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary effectiveness evaluating indicator:1）Primary patency rate	Proportion of patients with residual vessel diameter greater than 30% within 1 month and 6 months	1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:2）Revascularization rate of target vessels	Proportion of patients requiring reoperation for revascularization within 1 month and 6 months due to recurrence or worsening of symptoms caused by the original diseased vessel	1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:3）Rutherford grade	Rutherford classification can effectively evaluate the blood supply of patients' lower limbs	1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:4）Ankle-brachial index	Ankle-brachial index is generally the ratio of ankle systolic blood pressure to brachial artery systolic blood pressure. Ankle-brachial index is a test method to objectively determine the severity of limb ischemia	1 month, 6 months after surgery
Secondary effectiveness evaluating indicator:5)Instrument performance evaluation	Differences in the ablation effects of cold laser and excimer laser on lesions of different nature (thrombus, calcified plaque)	1 month
safety evaluating indicator:1) Major Adverse Event (MAE)	Including limb amputation and death due to inversion of diseased blood vessels	1 month, 6 months after surgery
safety evaluating indicator:2）Device-associated composite endpoint (Do CE)	Intraoperative device-induced distal embolization or postoperative vascular occlusion	1 month
safety evaluating indicator:3）Adverse events / Serious adverse events (AE / SAE)	Adverse events of perforation, dissection, and postoperative hematoma	1 month, 6 months after surgery
safety evaluating indicator:4）Incidence of device defects	For example, lesions in certain specific parts cannot be completely removed, etc.	1 month

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: First Affiliated Hospital Xi'an Jiaotong University; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Henan Provincial People's Hospital
• Investigators: Study Chair: Lianrui Guo, M.D., Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Atherectomy; cold laser plaque ablation; lower limb arterial stenosis; occlusive lesions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Constriction, Pathologic; Atherosclerosis
• Other Study ID Numbers: ZKRG-PAD-202304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No