Primary Coronary Artery CalcificationNCT07873736
SoniCrackerTM Single-use Intracoronary Shockwave Catheter
An observational study of Primary Coronary Artery Calcification, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd..
Trial summary
This study aims to observe the safety and effectiveness of the SoniCrackerTM single-use intracoronary shockwave catheter in the pretreatment and balloon dilation of primary coronary artery calcification lesions (coronary artery stenosis ≥50%) prior to stent implantation surgery in real-world patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Coronary Artery Calcification
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2028
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is used for pre-treatment and balloon dilation of primary coronary artery calcification lesions (coronary artery stenosis ≥50%) in adult patients before stent implantation surgery.
Who may be able to join
- Patients aged 18 and above;
- Patients with primary coronary artery calcification (coronary artery stenosis ≥50%) who are scheduled for stent implantation and deemed suitable for pretreatment with intracoronary shockwave therapy system and balloon dilation by the investigator before stent implantation;
- Patients who can understand the purpose of the trial, voluntarily participate, and sign the informed consent form.
Who cannot join
- Patients with other diseases (severe congestive heart failure and severe valvular disease, malignant tumors, organ transplant recipients or candidates) or a history of abuse (alcohol, cocaine, heroin, etc.);
- Patients who are pregnant or breastfeeding;
- Patients who are allergic to contrast media and cannot tolerate medications such as aspirin, clopidogrel, ticagrelor, and heparin;
- Researchers determined patients who could not tolerate the use of disposable intracoronary shockwave catheter through the lesion by angiography;
- Patients who were deemed unsuitable for participation in the study by researchers due to other reasons.
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
Official title: Real-world Observational Study on the Treatment of Primary Coronary Artery Calcified Lesions Using the SoniCrackerTM Single-use Intracoronary Shockwave Catheter
This study aims to observe the safety and effectiveness of the SoniCrackerTM single-use intracoronary shockwave catheter in the pretreatment and balloon dilation of primary coronary artery calcification lesions (coronary artery stenosis ≥50%) prior to stent implantation surgery in real-world patients.
- Conditions
- Primary Coronary Artery Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate
Measured: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days after surgery).
Secondary outcomes (2)
Device success rate:
The disposable intracoronary shockwave catheter successfully passed through the target lesion, dilated, completed shockwave pretreatment, and successfully decompressed and withdrew after treatment, with no immediate severe angiographic complications.
Measured: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days after surgery).
The incidence of MACE during hospitalization (up to 7 days post-surgery)
MACE includes: cardiac death, myocardial infarction, and target vessel revascularization [TVR]
Measured: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days after surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Coronary Artery CalcificationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
- Target duration
- 7 Days
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
- NCT07873736
- Sponsor's protocol ID
- LFBY-IVL-260112
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Observational Study on the Treatment of Primary Coronary Artery Calcified Lesions Using the SoniCrackerTM Single-use Intracoronary Shockwave Catheter
- ClinicalTrials.gov ID
- NCT07873736
- Acronym / sponsor ID
- LFBY-IVL-260112
- Conditions
- Primary Coronary Artery Calcification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Oct 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 study aims to observe the safety and effectiveness of the SoniCrackerTM single-use intracoronary shockwave catheter in the pretreatment and balloon dilation of primary coronary artery calcification lesions (coronary artery stenosis ≥50%) prior to stent implantation surgery in real-world patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is used for pre-treatment and balloon dilation of primary coronary artery calcification lesions (coronary artery stenosis ≥50%) in adult patients before stent implantation surgery.
Key inclusion criteria (3 listed)
- Patients aged 18 and above;
- Patients with primary coronary artery calcification (coronary artery stenosis ≥50%) who are scheduled for stent implantation and deemed suitable for pretreatment with intracoronary shockwave therapy system and balloon dilation by the investigator before stent implantation;
- Patients who can understand the purpose of the trial, voluntarily participate, and sign the informed consent form.
Key exclusion criteria (5 listed)
- Patients with other diseases (severe congestive heart failure and severe valvular disease, malignant tumors, organ transplant recipients or candidates) or a history of abuse (alcohol, cocaine, heroin, etc.);
- Patients who are pregnant or breastfeeding;
- Patients who are allergic to contrast media and cannot tolerate medications such as aspirin, clopidogrel, ticagrelor, and heparin;
- Researchers determined patients who could not tolerate the use of disposable intracoronary shockwave catheter through the lesion by angiography;
- Patients who were deemed unsuitable for participation in the study by researchers due to other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical success rate
Time frame: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days after surgery).
2 secondary outcomes
Device success rate:
Time frame: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days after surgery).
The incidence of MACE during hospitalization (up to 7 days post-surgery)
Time frame: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days 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 14 Oct 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Coronary Artery Calcification, 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 3 inclusion and 5 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 14 Oct 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 Zhangli Principal Investigator (159 2568 9811, li.zhang@shsmu.edu.cn), 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: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days 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 14 Oct 2026.