Coronary Artery DiseaseNCT05649488
Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus
A study testing Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus and Dragonfly Opstar Imaging Catheter in people with Coronary Artery Disease and Intravascular Lithotripsy, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. at 20 sites in China.
Trial summary
This is a prospective, multi-center, single-group target value clinical trial, which will be carried out in many clinical trial institutions in China. A total of 184 subjects (70 of them are OCT subgroups) are planned to be enrolled, all subjects were treated surgically with intracoronary lithotripsy using a balloon… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Intravascular Lithotripsy
- What is being tested?
- Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus and Dragonfly Opstar Imaging Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 20 sitesChina
- Study dates
- 9 Feb 2023to 22 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18-80 years, male or non-pregnant female.
- Evidence of symptomatic ischemia, stable or unstable angina, or MI for more than 7 days.
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to undergo angiography, OCT and clinical follow-up.
- Angiogram inclusion criteria
- The target lesion was primary and in situ coronary artery disease.
- Target lesion length ≤40 mm, target lesion reference vessel diameter 2.25-4.0 mm (visual inspection).
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- The target lesion diameter stenosis ≥70% or ≥50% (visual inspection) with evidence of ischemia.
- Clear, high-density shadows can be seen both when the heart is beating and when it is not.
- TIMI flow grade 3(allowing predilation) in the target vessel before use of the test equipment.
- The target lesion was the only calcified lesion to be treated with the shock wave, and the non-target lesion needed to be treated successfully before the target lesion.
- Suitable for patients undergoing metallic stent implantation
Who cannot join
- Severe myocardial infarction occurred within 7 days before operation.
- At the same time, the lesions were treated with rotational grinding or special balloon (chocolate balloon, nicked balloon, cutting balloon, double guide wire balloon, spinous process balloon, etc.).
- NYHA Class III or IV.
- Left ventricular ejection fraction <35% .
- The target lesion was expected to be treated by fully biodegradable stent implantation, drug balloon dilatation and PTCA.
- Uncontrollable severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg).
Show all 24Show fewer
- Severe hepatic and renal impairment, transaminase more than 3 times the upper limit of normal, serum creatinine > 2.5 mg/dL (221 μmol/L), or chronic kidney failure requiring long-term dialysis.
- Preoperative hemoglobin <100 g/l.
- Platelet count <60×109/L.
- Cerebral Stroke occurred within 6 months of enrollment, excluding transient ischemic attack (TIA) and lacunar infarction.
- A history of active peptic ulcer or upper gastrointestinal bleeding within 6 months before enrollment.
- Patients known to be allergic to heparin, contrast media, aspirin, clopidogrel and anesthetics.
- Definite diagnosis of malignancy or life expectancy would be less than 12 months.
- Participation in clinical trials of other drugs or medical devices that did not reach the primary end point.
- The researchers judged that the patients had poor compliance and could not complete the study according to the protocol.
- Angiographic exclusion criteria:
- The target lesion was in the opening position (LAD, LCX or RCA, within 5 mm of the opening) or unprotected left main coronary artery.
- Stents were implanted 10mm proximal or distal to the target lesion.
- The target lesion had unprotected branch vessels more than 2.5mm in diameter.
- The target lesion was distal to the saphenous vein or LIMA (Left internal mammary artery) /RIMA (Right internal mammary artery) bypass graft.
- Existed an aneurysm within 10mm of the target lesion.
- Angiography confirmed the presence of severe target lesion dissection (type D-F dissection (NHLBI classification) before the treatment of the Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus
- The target lesion had definite thrombosis.
- The researchers determined that the target lesion was unsuitable for vasodilation in patients.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites, 20 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, 100000
Wei Liu
- Not yet recruiting
Peking University People's Hospital
Beijing, 100044
Jian Liu
- Recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing, 102200
Ping Zhang
- Recruiting
Cangzhou Central Hospital
Cangzhou, Hebei, 061000
Jun Zhang
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Qian Tong
- Not yet recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Bin Liu
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Yong He
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Bo Zhang
- Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515
Jiancheng Xiu
- Recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514031
Zhixiong Zhong
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Yaling Han, Ph.D
Yaling Han, Ph.D
- Not yet recruiting
the 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
Shijiazhuang, Hebei, 050082
Leisheng Ru
- Not yet recruiting
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Bin Yang
- Recruiting
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024
Ziliang BaiBai
- Recruiting
Tianjin Chest Hospital
Tianjin, 300051
Qin Qin
- Not yet recruiting
TEDA International Cardiovascular Hospital
Tianjin, 300457
Rui Jing
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Xiang Cheng
- Not yet recruiting
People's Hospital of Wuhan University
Wuhan, Hubei, 430060
Hong Jiang
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Shaobin Jia
- Not yet recruiting
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan, 451450
Yan Chen
About this study
Official title: Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus for Preconditioning of Coronary Calcified Lesions in a Prospective, Multi-center, Single-group Clinical Trial
This is a prospective, multi-center, single-group target value clinical trial, which will be carried out in many clinical trial institutions in China. A total of 184 subjects (70 of them are OCT subgroups) are planned to be enrolled, all subjects were treated surgically with intracoronary lithotripsy using a balloon dilatation catheter and intracoronary lithotripsy apparatus after a single-group registration, clinical follow-up was carried out within 7 days after operation or before discharge, 1 month and 6 months after operation. The success rate of operation was taken as the main end point to verify the effectiveness of balloon dilatation catheter and intracoronary lithotripsy apparatus.
Read the detailed description
This is a prospective, multi-center, single-group target value clinical trial to recruit patients with coronary artery calcification, coronary artery calcification was pretreated with balloon dilatation catheter and intracoronary lithotripsy apparatus made by Shanghai Blusail Boyuan Medical Technology Co. , Ltd. , to verify the safety and efficacy of balloon dilatation catheter and intracoronary lithotripsy instrument for intravascular preconditioning of coronary artery calcification lesions. This trial will be carried out in many clinical trial institutions in China, and a total of 184 subjects (70 of them are OCT subgroups) are planned to be enrolled, all subjects were treated surgically with intracoronary lithotripsy using a balloon dilatation catheter and intracoronary lithotripsy apparatus after a single-group registration, clinical follow-up was carried out within 7 days after operation or before discharge, 1 month and 6 months after operation. In this study, the success rate of operation was taken as the main end point to verify the effectiveness of balloon dilatation catheter and intracoronary lithotripsy apparatus. A clinical summary report was issued for registration of the product 1 month after completion of postoperative follow-up, based on which a 6-month postoperative follow-up was performed to assess its safety. The secondary end points were angiographic success, device success, target lesion failure at 1 and 6 months, severe angiographic complications, MACE events at 1 and 6 months, serious adverse events and adverse events, and device defects. In the OCT Subgroup, the secondary end points were the minimum stent area (MSA), the minimum stent lumen diameter (MLD), the lumen acquired diameter, the lumen acquired area, and the lumen acquired rate of the immediate postoperative, the expansion rate of the stent, and the incomplete adherence rate of the stent beam.
- Conditions
- Coronary Artery Disease, Intravascular Lithotripsy
- Being tested
- Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus, Dragonfly Opstar Imaging Catheter
- 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.
Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatusDevice
Introduction: After the preparation, release the intracoronary lithotripsy balloon catheter to the area to be treated and release the shock wave pulse for treatment. After the balloon reaches the predetermined position, use angiography to lock the position and fill the balloon to 6 atm. After the shock wave pulse therapy, the balloon was expanded to 8 atm according to the balloon compliance table and lasted for 10s. After the treatment, unload the balloon pressure, wait for the blood flow to recover, and repeat the second treatment after an interval of one minute, two cycles, releasing a total of 20 shock wave pulses as a treatment cycle.
Therapeutic apparatus specification: IVL-HVG-C01； Specifications of balloon catheter: C20012, C20015, C22512, C22515, C25012, C25015, C27512, C27515, C30012, C30015, C32512, C32515, C35012, C35015, C37512, C37515, C40012, C40015
Dragonfly Opstar Imaging CatheterDevice
OCT (optical coherence tomography) measurement using Dragonfly Opstar Imaging Catheter was performed in the OCT subgroup before or after the treatment of intracoronary lithotripsy balloon catheter and intracoronary lithotripsy therapeutic instrument, or after stent placement.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 184 patients were enrolled in the experimental group Receives: Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus |
| Optical Coherence Tomography Subgroup | Other | 70 patients in the test group were enrolled in the OCT subgroup. Receives: Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus; Device: Dragonfly Opstar Imaging Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation success rate
After successful stent placement, the residual stenosis in the stent is ≤ 30%, and there is no residual stenosis during hospitalization (up to 7 days after surgery at most) MACE event occurs
Measured: During hospitalization (up to 7 days after operation)
Secondary outcomes (7)
Angiographic success rate (residual stenosis ≤ 30%)
Efficacy endpoint
Measured: Immediately after operation
Incidence rate of MACE events 1 month and 6 months after operation
Security endpoint
Measured: 6 months after operation
Target lesion failure (TLF) rate 1 month and 6 months after operation
Security endpoint
Measured: 6 months after operation
Device success rate
Security endpoint
Measured: 6 months after operation
Incidence of serious angiographic complications
Security endpoint
Measured: 6 months after operation
Incidence rate of serious adverse events and adverse events
Security endpoint
Measured: 6 months after operation
Incidence rate of device defects
Security endpoint
Measured: 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start9 Feb 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion22 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaling Han, Ph.D, Principal investigator, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649488
- Sponsor's protocol ID
- LFBY-202201
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu H, Xiu J, Qin Q, Bai Z, Tong Q, Jia S, Zhang P, Zhang J, Zhong Z, Liu W, He Y, Jing Q, Han Y. Efficacy and safety of the SoniCracker intravascular lithotripsy device for severely calcified coronary lesions: the LEAD-FIM study from China. BMC Cardiovasc Disord. 2025 Dec 30;26(1):127. doi: 10.1186/s12872-025-05447-4.
PubMed 41469559
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus for Preconditioning of Coronary Calcified Lesions in a Prospective, Multi-center, Single-group Clinical Trial
- ClinicalTrials.gov ID
- NCT05649488
- Acronym / sponsor ID
- LFBY-202201
- Conditions
- Coronary Artery Disease, Intravascular Lithotripsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 22 Sep 2025 (estimated)
- First posted
- 14 Dec 2022 (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 is a prospective, multi-center, single-group target value clinical trial, which will be carried out in many clinical trial institutions in China. A total of 184 subjects (70 of them are OCT subgroups) are planned to be enrolled, all subjects were treated surgically with intracoronary lithotripsy using a balloon dilatation catheter and intracoronary lithotripsy apparatus after a single-group registration, clinical follow-up was carried out within 7 days after operation or before discharge, 1 month and 6 months after operation. The success rate of operation was taken as the main end point to verify the effectiveness of balloon dilatation catheter and intracoronary lithotripsy apparatus.
Detailed description
This is a prospective, multi-center, single-group target value clinical trial to recruit patients with coronary artery calcification, coronary artery calcification was pretreated with balloon dilatation catheter and intracoronary lithotripsy apparatus made by Shanghai Blusail Boyuan Medical Technology Co. , Ltd. , to verify the safety and efficacy of balloon dilatation catheter and intracoronary lithotripsy instrument for intravascular preconditioning of coronary artery calcification lesions. This trial will be carried out in many clinical trial institutions in China, and a total of 184 subjects (70 of them are OCT subgroups) are planned to be enrolled, all subjects were treated surgically with intracoronary lithotripsy using a balloon dilatation catheter and intracoronary lithotripsy apparatus after a single-group registration, clinical follow-up was carried out within 7 days after operation or before discharge, 1 month and 6 months after operation. In this study, the success rate of operation was taken as the main end point to verify the effectiveness of balloon dilatation catheter and intracoronary lithotripsy apparatus. A clinical summary report was issued for registration of the product 1 month after completion of postoperative follow-up, based on which a 6-month postoperative follow-up was performed to assess its safety. The secondary end points were angiographic success, device success, target lesion failure at 1 and 6 months, severe angiographic complications, MACE events at 1 and 6 months, serious adverse events and adverse events, and device defects. In the OCT Subgroup, the secondary end points were the minimum stent area (MSA), the minimum stent lumen diameter (MLD), the lumen acquired diameter, the lumen acquired area, and the lumen acquired rate of the immediate postoperative, the expansion rate of the stent, and the incomplete adherence rate of the stent beam.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus184 patients were enrolled in the experimental group |
| Optical Coherence Tomography Subgroup | Other | Device: Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus, Device: Dragonfly Opstar Imaging Catheter70 patients in the test group were enrolled in the OCT subgroup. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-80 years, male or non-pregnant female.
- Evidence of symptomatic ischemia, stable or unstable angina, or MI for more than 7 days.
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to undergo angiography, OCT and clinical follow-up.
- Angiogram inclusion criteria
- The target lesion was primary and in situ coronary artery disease.
Key exclusion criteria (24 listed)
- Severe myocardial infarction occurred within 7 days before operation.
- At the same time, the lesions were treated with rotational grinding or special balloon (chocolate balloon, nicked balloon, cutting balloon, double guide wire balloon, spinous process balloon, etc.).
- NYHA Class III or IV.
- Left ventricular ejection fraction <35% .
- The target lesion was expected to be treated by fully biodegradable stent implantation, drug balloon dilatation and PTCA.
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 |
|---|---|---|
| Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatusIntroduction: After the preparation, release the intracoronary lithotripsy balloon catheter to the area to be treated and release the shock wave pulse for treatment. After the balloon reaches the predetermined position, use angiography to lock the position and fill the balloon to 6 atm. After the shock wave pulse therapy, the balloon was expanded to 8 atm according to the balloon compliance table and lasted for 10s. After the treatment, unload the balloon pressure, wait for the blood flow to recover, and repeat the second treatment after an interval of one minute, two cycles, releasing a total of 20 shock wave pulses as a treatment cycle. Therapeutic apparatus specification: IVL-HVG-C01； Specifications of balloon catheter: C20012, C20015, C22512, C22515, C25012, C25015, C27512, C27515, C30012, C30015, C32512, C32515, C35012, C35015, C37512, C37515, C40012, C40015 | Device | Experimental group, Optical Coherence Tomography Subgroup |
| Dragonfly Opstar Imaging CatheterOCT (optical coherence tomography) measurement using Dragonfly Opstar Imaging Catheter was performed in the OCT subgroup before or after the treatment of intracoronary lithotripsy balloon catheter and intracoronary lithotripsy therapeutic instrument, or after stent placement. | Device | Optical Coherence Tomography Subgroup |
Primary outcome
Operation success rate
Time frame: During hospitalization (up to 7 days after operation)
After successful stent placement, the residual stenosis in the stent is ≤ 30%, and there is no residual stenosis during hospitalization (up to 7 days after surgery at most) MACE event occurs
7 secondary outcomes
Angiographic success rate (residual stenosis ≤ 30%)
Time frame: Immediately after operation
Incidence rate of MACE events 1 month and 6 months after operation
Time frame: 6 months after operation
Target lesion failure (TLF) rate 1 month and 6 months after operation
Time frame: 6 months after operation
Device success rate
Time frame: 6 months after operation
Incidence of serious angiographic complications
Time frame: 6 months after operation
Incidence rate of serious adverse events and adverse events
Time frame: 6 months after operation
Incidence rate of device defects
Time frame: 6 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 41469559Liu H, Xiu J, Qin Q, Bai Z, Tong Q, Jia S, Zhang P, Zhang J, Zhong Z, Liu W, He Y, Jing Q, Han Y. Efficacy and safety of the SoniCracker intravascular lithotripsy device for severely calcified coronary lesions: the LEAD-FIM study from China. BMC Cardiovasc Disord. 2025 Dec 30;26(1):127. doi: 10.1186/s12872-025-05447-4.
- 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. This study is not recruiting at the moment.
Yaling Han, Ph.D principal investigator
The General Hospital of Northern Theater Command
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus and Dragonfly Opstar Imaging Catheter in people with Coronary Artery Disease and Intravascular Lithotripsy, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. at 20 sites 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 11 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanjiao Zhang, PM (+8613889120902, yanjiao.zhang@jwmsgrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation success rate (time frame: During hospitalization (up to 7 days after operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649488, which also lists 1 linked publication.
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 13 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.