A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Trial Evaluating the Safety and Efficacy of Single-use Peripheral Intravascular Shock Wave Catheters Combined With Intravascular Shock Wave Therapy Devices for Peripheral Artery Calcified Lesions.

This trial is a prospective, multicenter, randomized, parallel controlled clinical trial. It to recruit patients with peripheral arterial calcified lesions, who will be randomly assigned in a 1:1 ratio to either the group or the control group. Subjects in the experimental group will use a disposable intra-peripheral vascularwave catheter combined with an intravascular shockwave therapy device to treat peripheral arterial calcified lesions and perform balloon dilation, while subjects in the control group will use a peripheral balloon dilation catheter to treat peripheral arterial calcified lesions and perform balloon dilation.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Peripheral Artery Calcified Lesions
• Intervention / Treatment: Procedure: Interventional therapy in the experimental group; Procedure: Interventional therapy in the control group

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lu Xinwu Principal Investigator; Phone Number: 86-21-23271699; Email: luxw1654@sh9hospital.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

General selection criteria

1. Age 18 to 80 years old, regardless of gender;
2. Rutherford grade is 2 to 5
3. As judged by the investigator, peripheral endovascular treatment is required;
4. The subject or their legal guardian has been informed of the purpose of the trial, consents to participate and signs the informed consent form;
5. The subject is willing comply with all assessment requirements in the trial;

Inclusion criteria for angiography:

1) Target lesions are vascular calcified lesions of grade Ⅲ to Ⅳ according to PARC classification: 2 Target lesions are located in native femoral artery and/or popliteal artery; 3) Total of target lesion ≤260mm; if it contains occlusive lesion, length of occlusive segment ≤100mm and total length of target lesion ≤20mm; 4) Target lesions have not undergone any surgical interventions including endovascular therapy and open surgery before, and the stenosis degree target lesion is ≥70% (visual assessment); 5) Reference vessel diameter of target is between 2.5mm and 8.0mm; 6) At least one distal outflow tract of target lesion is (vascular stenosis degree ≤50% by visual assessment), with blood flow reaching foot (not dependent on collateral circulation); or the patient has successfully undergone treatment for target lesion before (i.e., residual stenosis degree ≤30% by visual assessment after treatment, without serious complications); 7) The ipsilateral inflow tract of target lesion is patent (vascular stenosis degree ≤50% by visual assessment), or the patient has successfully undergone treatment for lesion before (i.e., residual stenosis degree ≤30% by visual assessment treatment, without serious complications);

Exclusion Criteria:

General Exclusion Criteria

1. History of amputation of target limb or planned major amputation (above the ankle
2. INR > 3 or platelet count < 60×10^9/L;
3. Patients with known renal insufficiency (ser creatinine >2.5 mg/dL or 220 μmol/L) or renal failure requiring long-term dialysis;
4. Patients with known contraindications to antiplatelet andagulant therapy;
5. Patients with known allergies to contrast agents used in endovascular therapy and experimental device materials;
6. Patients who have receivedbolytic therapy in the target vessel within 14 days prior to signing informed consent; ) Patients who have experienced myocardial infarction within 60 days prior to signing informed consent;

8) Patients who have experienced stroke within 60 days prior to signing informed consent; 9) Women of childbearing age who are pregnant, breastfeeding or planning pregnancy; 10) Patients participating in other medical device or drug clinical trials; 11) Other reasons considered by the investigator as inappropriate for participation in the trial.

Angiography exclusion criteria:

1. The target vessel has evidence of aneurysm or acute/chronic thrombosis;
2. The vessel is highly tortuous (the visual arc is greater than 30°);
3. The guidewire cannot pass through the target lesion; 4 There is in-stent restenosis in the target lesion area;

5) Before treating the lesion with research devices, ablative devices such as cutting balloons, scoring balloons, compliant balloons, mammillary balloons, pronged balloons, plaque excision devices, excimer laser systems, and peripheral throm aspiration catheters need to be used.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; The subjects in the experimental group used disposable peripheral intravascular shockwave catheters with intravascular shockwave therapy devices to treat peripheral artery calcification lesions and perform balloon dilatation.	Procedure: Interventional therapy in the experimental group; The subjects in the experimental group used disposable peripheral intravascular shockwave catheters combined with intravascular shockwave therapy devices to treat peripheral artery calcification lesions and perform balloon dilatation.
Experimental: control group; The subjects in the control group used peripheral balloon dilatation catheters to treat artery calcified lesions and conduct balloon dilatation.	Procedure: Interventional therapy in the control group; The subjects in the control group used peripheral balloon dilatation catheters to treat peripheral artery calcified lesions and conduct balloon dilatation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	After treatment with the investigational device, residual diameter stenosis of the target lesion is ≤0% and no dissection of grade ≥D is present.	immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate	The interventional device successfully reached the lesion site, achieved successful expansion without any rupture, was successfully withdrawn.	immediately after surgery
Primary patency rate of target lesions at 30 days after operation	No clinically driven target lesion revascularization (CD-TLR) and no target lesionosis detected by imaging examinations	30 days after operation
Changes in ankle-brachial index at 7 days postoperatively or on the day discharge, and at 30 days postoperatively.		7 days post-operation or the day of discharge, 30 days post-operation
Changes in Rutherford grade at 7 days postoperatively or discharge day, 3 days postoperatively, and 6 months postoperatively	Changes in Rutherford grade at 7 days postoperatively or discharge day, 3 days postoperatively, and 6 months postoperatively	7 days after surgery or discharge date, 30 days after surgery, 6 months surgery
Incidence rate of clinically driven target lesion revascularization (CD-TLR) at30 days and 6 months after surgery	Incidence rate of clinically driven target lesion revascularization (CD-TLR) at30 days and 6 months after surgery	30 days after surgery, 6 months after surgery

Collaborators and Investigators

• Sponsor: Shanghai Bluesail Boyuan Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: September 11, 2026
• First Submitted That Met QC Criteria: September 18, 2026
• First Posted (Actual): September 24, 2026

Study Record Updates

• Last Update Posted (Actual): September 24, 2026
• Last Update Submitted That Met QC Criteria: September 18, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LFBYIVL-202512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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