Coronary Artery DiseaseNCT06924736
SONICURE（SONICracker for the Treatment of UndeRExpansion）
A study testing Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter and Non - compliant balloon dilatation catheter in people with Coronary Artery Disease, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. at 1 site in China.
Trial summary
The first-phase study is a prospective, single-group observational study. It plans to recruit patients with in-stent restenosis caused by poor stent expansion in the coronary artery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter and Non - compliant balloon dilatation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 31 Dec 2026
- 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
- Aged between 18 and 80 years old, either male or non - pregnant female.
- Suffering from heart diseases with clinical evidence of ischemia, such as Chronic Coronary Syndrome (CCS) or Acute Coronary Syndrome (ACS).
- The subject should be able to understand the purpose of the trial, voluntarily participate in it, and sign the informed consent form.
- During the baseline surgery, at most one target lesion can be treated.
- The target lesion and non - target lesion are not located in the same blood vessel.
- The reference vessel diameter of the target lesion is 2.25 - 4.0 mm (estimated visually).
Who cannot join
- Patients who have had any myocardial infarction within 1 week, or patients who have had a myocardial infarction more than 1 week ago but whose myocardial enzymes CK or CK-MB have not yet returned to normal.
- Patients with New York Heart Association (NYHA) class III or IV heart failure or those with severe valvular heart disease.
- Female patients who are planning to become pregnant (or are breastfeeding).
- Severe impairment of liver and kidney function, with transaminase levels more than 3 times the upper limit of the normal value, serum creatinine > 2.5 mg/dL (221 μmol/L), or chronic renal failure requiring long-term dialysis.
- Severe hypertension that cannot be controlled despite treatment (systolic blood pressure persistently > 180 mmHg or diastolic blood pressure persistently > 110 mmHg).
- Coagulation disorders, with a platelet count < 100×10⁹/L.
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- Patients with cardiogenic shock.
- Patients who need to receive cytostatic agents or radiotherapy due to accompanying diseases.
- Patients known to be allergic to heparin, contrast agents, aspirin, clopidogrel, or anesthetics.
- Patients with a bleeding diathesis, or those with a history of cerebral hemorrhage, active peptic ulcer, or gastrointestinal bleeding within the past 6 months, for whom anticoagulant therapy or the use of anticoagulant drugs will be restricted or prohibited.
- Patients with a life expectancy of less than 6 months or those with potential factors that may cause difficulties in clinical follow-up.
- Patients who are currently participating in any other clinical trial. Patients who, for other reasons, are considered by the investigator to be unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yuanchun Sun contact
China1 site
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Guangyao Zhai, 010-69543901-1081, ml.zuo@jwmsgrp.com
About this study
Official title: Evaluate the Safety and Effectiveness of the Intravascular Shock Wave Treatment Device and the Disposable Coronary Intravascular Shock Wave Catheter Compared With the Non-compliant Balloon Catheter in the Treatment of In-stent Restenosis of the Coronary Artery
The first-phase study is a prospective, single-group observational study. It plans to recruit patients with in-stent restenosis caused by poor stent expansion in the coronary artery. The intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd. will be used for treatment. This is a clinical trial to verify the feasibility, preliminary safety and effectiveness of treating in-stent restenosis caused by poor stent expansion in the coronary artery.
The second-phase study is a prospective, multicenter, randomized controlled clinical trial is planned to recruit patients with in - stent restenosis caused by poor coronary stent expansion. These patients will be treated with either the intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd., or a non - compliant balloon dilation catheter (Shandong JW Medical Products Co., Ltd., National Medical Device Registration No. 20213031019). The purpose is to verify the safety and effectiveness of the investigational medical devices in treating in - stent restenosis caused by poor coronary stent expansion.
Read the detailed description
In the first phase, it will be carried out at Beijing Luhe Hospital, Capital Medical University. A total of 10 subjects are planned to be enrolled. After the subjects are included in the study, they will be treated with the intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd. Clinical follow-ups will be conducted before discharge and one month after the operation.
In the second phase, it will be carried out at multiple clinical trial institutions in China. A total of 200 subjects are planned to be enrolled. After randomization, all subjects will undergo surgical treatment using either the investigational device or the control device. Clinical follow - up will be conducted before discharge, 1 month after surgery, and 6 months after surgery.
- Conditions
- Coronary Artery Disease
- Being tested
- Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter, Non - compliant balloon dilatation catheter
- Keywords
- SONICURE
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave CatheterDevice
Randomly assign subjects to the experimental group to treat the lesions with an intravascular shockwave therapy device/disposable coronary artery shockwave catheter.
Non - compliant balloon dilatation catheterDevice
Randomly assign subjects to the control group to treat the lesions with a non - compliant balloon catheter.
| Study group | Role | What they receive |
|---|---|---|
| Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter | Experimental | Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter (Shanghai Lanfan Boyuan Medical Technology Co., Ltd.) Receives: Device: Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter |
| non-compliant balloon dilatation catheter | Active comparator | Randomized to the control group using a non-compliant balloon dilatation catheter (Shandong Jiwei Medical Products Co., Ltd.) to treat the lesion Receives: Device: Non - compliant balloon dilatation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate
The residual stenosis after the operation is ≤ 30%, and there is no occurrence of Major Adverse Cardiac Events (MACE) during the hospitalization period (up to 7 days after the operation).
Measured: during the hospitalization period (up to 7 days after the operation).
Secondary outcomes (8)
Device success rate
Security endpoint
Measured: Immediately after the operation
The minimum stent area immediately after the operation（MSA）
Measured by Optical Coherence Tomography (OCT)
Measured: Immediately after the operation
The minimum stent lumen diameter immediately after the operation（MLD）
Measured by Optical Coherence Tomography (OCT)
Measured: Immediately after the operation
The incidence of Major Adverse Cardiovascular Events (MACE)
Safety endpoint
Measured: before discharge, one month after the operation
The incidence of target lesion failure (TLF)
Safety endpoint
Measured: one month after the operation
The incidence of serious adverse events
Safety endpoint
Measured: before discharge, one month after the operation
The incidence of device defects
Safety endpoint
Measured: during the operation
The incidence of serious angiographic complications
Safety endpoint
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guangyao Zhai, Principal investigator, Beijing Luhe Hospital Affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924736
- Sponsor's protocol ID
- LFBY-202503
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Effectiveness of the Intravascular Shock Wave Treatment Device and the Disposable Coronary Intravascular Shock Wave Catheter Compared With the Non-compliant Balloon Catheter in the Treatment of In-stent Restenosis of the Coronary Artery
- ClinicalTrials.gov ID
- NCT06924736
- Acronym / sponsor ID
- LFBY-202503
- Conditions
- Coronary Artery Disease
- Keywords
- SONICURE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 2025 (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.
The first-phase study is a prospective, single-group observational study. It plans to recruit patients with in-stent restenosis caused by poor stent expansion in the coronary artery. The intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd. will be used for treatment. This is a clinical trial to verify the feasibility, preliminary safety and effectiveness of treating in-stent restenosis caused by poor stent expansion in the coronary artery.
The second-phase study is a prospective, multicenter, randomized controlled clinical trial is planned to recruit patients with in - stent restenosis caused by poor coronary stent expansion. These patients will be treated with either the intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd., or a non - compliant balloon dilation catheter (Shandong JW Medical Products Co., Ltd., National Medical Device Registration No. 20213031019). The purpose is to verify the safety and effectiveness of the investigational medical devices in treating in - stent restenosis caused by poor coronary stent expansion.
Detailed description
In the first phase, it will be carried out at Beijing Luhe Hospital, Capital Medical University. A total of 10 subjects are planned to be enrolled. After the subjects are included in the study, they will be treated with the intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd. Clinical follow-ups will be conducted before discharge and one month after the operation.
In the second phase, it will be carried out at multiple clinical trial institutions in China. A total of 200 subjects are planned to be enrolled. After randomization, all subjects will undergo surgical treatment using either the investigational device or the control device. Clinical follow - up will be conducted before discharge, 1 month after surgery, and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter | Experimental | Device: Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave CatheterIntravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter (Shanghai Lanfan Boyuan Medical Technology Co., Ltd.) |
| non-compliant balloon dilatation catheter | Active comparator | Device: Non - compliant balloon dilatation catheterRandomized to the control group using a non-compliant balloon dilatation catheter (Shandong Jiwei Medical Products Co., Ltd.) to treat the lesion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 80 years old, either male or non - pregnant female.
- Suffering from heart diseases with clinical evidence of ischemia, such as Chronic Coronary Syndrome (CCS) or Acute Coronary Syndrome (ACS).
- The subject should be able to understand the purpose of the trial, voluntarily participate in it, and sign the informed consent form.
- During the baseline surgery, at most one target lesion can be treated.
- The target lesion and non - target lesion are not located in the same blood vessel.
Key exclusion criteria (12 listed)
- Patients who have had any myocardial infarction within 1 week, or patients who have had a myocardial infarction more than 1 week ago but whose myocardial enzymes CK or CK-MB have not yet returned to normal.
- Patients with New York Heart Association (NYHA) class III or IV heart failure or those with severe valvular heart disease.
- Female patients who are planning to become pregnant (or are breastfeeding).
- Severe impairment of liver and kidney function, with transaminase levels more than 3 times the upper limit of the normal value, serum creatinine > 2.5 mg/dL (221 μmol/L), or chronic renal failure requiring long-term dialysis.
- Severe hypertension that cannot be controlled despite treatment (systolic blood pressure persistently > 180 mmHg or diastolic blood pressure persistently > 110 mmHg).
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 |
|---|---|---|
| Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave CatheterRandomly assign subjects to the experimental group to treat the lesions with an intravascular shockwave therapy device/disposable coronary artery shockwave catheter. | Device | Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter |
| Non - compliant balloon dilatation catheterRandomly assign subjects to the control group to treat the lesions with a non - compliant balloon catheter. | Device | non-compliant balloon dilatation catheter |
Primary outcome
Surgical success rate
Time frame: during the hospitalization period (up to 7 days after the operation).
The residual stenosis after the operation is ≤ 30%, and there is no occurrence of Major Adverse Cardiac Events (MACE) during the hospitalization period (up to 7 days after the operation).
8 secondary outcomes
Device success rate
Time frame: Immediately after the operation
The minimum stent area immediately after the operation（MSA）
Time frame: Immediately after the operation
The minimum stent lumen diameter immediately after the operation（MLD）
Time frame: Immediately after the operation
The incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: before discharge, one month after the operation
The incidence of target lesion failure (TLF)
Time frame: one month after the operation
The incidence of serious adverse events
Time frame: before discharge, one month after the operation
The incidence of device defects
Time frame: during the operation
The incidence of serious angiographic complications
Time frame: during the operation
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 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Yuanchun Sun contact
Guangyao Zhai principal investigator
Beijing Luhe Hospital Affiliated to Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter and Non - compliant balloon dilatation catheter in people with Coronary Artery Disease, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. at 1 site in China.
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 6 inclusion and 12 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 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yang Wang (13366024088, yang.wang@jwmsgrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success rate (time frame: during the hospitalization period (up to 7 days after the operation).). 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 11 Apr 2025.