Patients With Peripheral Artery Calcified LesionsNCT07839143
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.
A study testing Interventional therapy in the experimental group in people with Patients With Peripheral Artery Calcified Lesions, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients With Peripheral Artery Calcified Lesions
- What is being tested?
- Interventional therapy in the experimental group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General selection criteria
- Age 18 to 80 years old, regardless of gender;
- Rutherford grade is 2 to 5
- As judged by the investigator, peripheral endovascular treatment is required;
- The subject or their legal guardian has been informed of the purpose of the trial, consents to participate and signs the informed consent form;
- The subject is willing comply with all assessment requirements in the trial;
- 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);
Who cannot join
- General Exclusion Criteria
- History of amputation of target limb or planned major amputation (above the ankle
- INR > 3 or platelet count < 60×10^9/L;
- Patients with known renal insufficiency (ser creatinine >2.5 mg/dL or 220 μmol/L) or renal failure requiring long-term dialysis;
- Patients with known contraindications to antiplatelet andagulant therapy;
- Patients with known allergies to contrast agents used in endovascular therapy and experimental device materials;
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- 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:
- The target vessel has evidence of aneurysm or acute/chronic thrombosis;
- The vessel is highly tortuous (the visual arc is greater than 30°);
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Interventional therapy in the experimental group, Interventional therapy in the control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional therapy in the experimental groupProcedure or surgery
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.
Interventional therapy in the control groupProcedure or surgery
The subjects in the control group used peripheral balloon dilatation catheters to treat peripheral artery calcified lesions and conduct balloon dilatation.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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. Receives: Procedure: Interventional therapy in the experimental group |
| control group | Experimental | The subjects in the control group used peripheral balloon dilatation catheters to treat artery calcified lesions and conduct balloon dilatation. Receives: Procedure: Interventional therapy in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after surgery
Secondary outcomes (5)
Device success rate
The interventional device successfully reached the lesion site, achieved successful expansion without any rupture, was successfully withdrawn.
Measured: 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
Measured: 30 days after operation
Changes in ankle-brachial index at 7 days postoperatively or on the day discharge, and at 30 days postoperatively.
Measured: 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
Measured: 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
Measured: 30 days after surgery, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Peripheral Artery Calcified LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839143
- Sponsor's protocol ID
- LFBYIVL-202512
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07839143
- Acronym / sponsor ID
- LFBYIVL-202512
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Interventional therapy in the experimental groupThe 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. |
| control group | Experimental | Procedure: Interventional therapy in the control groupThe subjects in the control group used peripheral balloon dilatation catheters to treat artery calcified lesions and conduct balloon dilatation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- General selection criteria
- Age 18 to 80 years old, regardless of gender;
- Rutherford grade is 2 to 5
- As judged by the investigator, peripheral endovascular treatment is required;
- The subject or their legal guardian has been informed of the purpose of the trial, consents to participate and signs the informed consent form;
Key exclusion criteria (13 listed)
- General Exclusion Criteria
- History of amputation of target limb or planned major amputation (above the ankle
- INR > 3 or platelet count < 60×10^9/L;
- Patients with known renal insufficiency (ser creatinine >2.5 mg/dL or 220 μmol/L) or renal failure requiring long-term dialysis;
- Patients with known contraindications to antiplatelet andagulant therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional therapy in the experimental groupThe 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. | Procedure or surgery | experimental group |
| Interventional therapy in the control groupThe subjects in the control group used peripheral balloon dilatation catheters to treat peripheral artery calcified lesions and conduct balloon dilatation. | Procedure or surgery | control group |
Primary outcome
Technical success rate
Time frame: immediately after surgery
After treatment with the investigational device, residual diameter stenosis of the target lesion is ≤0% and no dissection of grade ≥D is present.
5 secondary outcomes
Device success rate
Time frame: immediately after surgery
Primary patency rate of target lesions at 30 days after operation
Time frame: 30 days after operation
Changes in ankle-brachial index at 7 days postoperatively or on the day discharge, and at 30 days postoperatively.
Time frame: 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
Time frame: 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
Time frame: 30 days after surgery, 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional therapy in the experimental group in people with Patients With Peripheral Artery Calcified Lesions, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Xinwu Principal Investigator (86-21-23271699, luxw1654@sh9hospital.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.