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

Atherosclerosis of Artery Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211127
• Other study ID #: ZKRG-PAD-202304
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Lianrui Guo, M.D.
• Phone: +8613671009746
• Email: lianruiguo[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Disease of Legs
• Atherosclerosis
• Atherosclerosis of Artery
• Constriction, Pathologic

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	First Affiliated Hospital Xi'an Jiaotong University, Henan Provincial People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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	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
Secondary	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
Secondary	safety evaluating indicator:2)Device-associated composite endpoint (Do CE)	Intraoperative device-induced distal embolization or postoperative vascular occlusion	1 month
Secondary	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
Secondary	safety evaluating indicator:4)Incidence of device defects	For example, lesions in certain specific parts cannot be completely removed, etc.	1 month