Cardiovascular DiseasesNCT07259239
SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study
A study testing Medical device in people with Cardiovascular Diseases, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
Interventional cardiologists are facing an increasing burden of calcified coronary arteries in keeping with an ageing population and rising prevalence of diabetes mellitus and chronic kidney disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Sep 2025to Jul 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at age ≥ 21 years old.
- Patients undergoing elective/ planned PCI with at least moderate coronary calcification on angiography at the target lesion are eligible for enrolment. Moderate coronary calcification is defined as densities on only one side of the arterial wall prior to contrast injection. Severe calcification was defined as radiopacities on both sides of the arterial wall prior to contrast injection.
- Patients need to demonstrate evidence of either a 180 arc of coronary calcium or nodular calcium at the target lesion on intravascular imaging prior to IVL therapy.
Who cannot join
- Significant co-morbidities:
- Cardiac arrest
- Cardiogenic shock
- Collapse / comatose / semi-conscious states
- Patients requiring urgent or emergent PCI.
- Patients who are unable to provide consent.
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- Patients who are pregnant.
- Breast-feeding women
- Any patients whom the Investigator deems unsuitable for the study (e.g., due to other medical reasons, laboratory abnormalities, expected study medication noncompliance, or subject's unwillingness to comply with all study-related study procedures).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Center Singapore
Singapore, 169609
Yann Shan Keh, 93892179, keh.yann.shan@singhealth.com.sg
Yann Shan Keh
About this study
Interventional cardiologists are facing an increasing burden of calcified coronary arteries in keeping with an ageing population and rising prevalence of diabetes mellitus and chronic kidney disease. Heavily calcified plaques impede balloon dilatation and successful stent delivery, resulting stent under-expansion, malposition, and damage to the drug-eluting polymer coats. This translates to poorer procedural outcomes and increased risk of Major Adverse Cardiovascular Events (MACE). The investigators' proposal seeks to determine the feasibility of the SoniCracker IVL in patients with calcified coronary lesions.
Read the detailed description
Coronary calcifications are one of the strongest predictors of adverse intraprocedural and long-term PCI outcomes. We believe SoniCraker IVL provides a safer and less aggressive method of calcium modification as opposed to traditional coronary atherectomy, hence translating into better clinical outcomes for patient. Although there is a commercially available IVL (Shockwave balloon) available, it is currently priced at ~ SGD 4000. The SoniCracker IVL is potentially a more cost-effective alternative to the Shockwave IVL.
- Conditions
- Cardiovascular Diseases
- Being tested
- Medical device
- Keywords
- SING-IVL
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical deviceDevice
The SoniCracker IVL is a rapid-exchange catheter with an effective length of 1420mm, with two radiopaque markers at the distal end and is coated with a hydrophilic coating from the distal tip to the wire exchange port to facilitate tracking and catheter delivery during use. The catheter lumen consists of a wire lumen, an inflation lumen, and two shockwave electrodes. The wire lumen allows passage of a 0.014" guidewire to guide the catheter into and through the lesion. The inflation lumen is filled with a 50%/50% mixture of physiological saline and contrast media to inflate and deflate the balloon. The electrode traverses the entire effective length of the catheter for lithotripsy treatment. The proximal end of the catheter features a hub with two ports, one for inflation/deflation of the balloon, and the other for connecting the electrode wires to the Coronary intravascular lithotripsy therapy device.
| Study group | Role | What they receive |
|---|---|---|
| SoniCracker IVL | Experimental | Not described Receives: Device: Medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Successful delivery and deployment of the study device, and attainment of less than 50% diameter stenosis after stenting with no evidence of in-hospital major adverse cardiac events (MACE: cardiac death, myocardial infarction or target vessel revascularization)
Measured: Perioperative
Secondary outcomes (1)
Device success (successful delivery and deployment of a device, and attainment of less than 50% diameter stenosis), 30-day MACE, coronary complications, post procedural angiographic and intravascular imaging outcomes
Measured: Up to 30 days (+ 1 month) post PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start30 Sep 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- At baseline, enrolled participants will be treated with the study device - SoniCracker Intravascular Lithotripsy Balloon during routine percutaneous coronary intervention (PCI). This device consists of a single-use, sterile catheter with multiple emitters mounted on a coronary balloon. The balloon is inserted into the coronary arteries. The emitters on the balloon then create shockwaves that cause cracks the calcium of the coronary arteries. The catheter is removed after the procedure. The rest of the PCI will be performed as per regular care. At 30 days post PCI procedure, participants will be followed up via telephone calls.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Biosensor Interventional Technologies Pte Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259239
- Sponsor's protocol ID
- 2025-0308
- Status last verified
- Jun 2025
- First submitted
- 1 Oct 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study
- ClinicalTrials.gov ID
- NCT07259239
- Acronym / sponsor ID
- 2025-0308
- Conditions
- Cardiovascular Diseases
- Keywords
- SING-IVL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Biosensor Interventional Technologies Pte Ltd
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 2 Dec 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.
Interventional cardiologists are facing an increasing burden of calcified coronary arteries in keeping with an ageing population and rising prevalence of diabetes mellitus and chronic kidney disease. Heavily calcified plaques impede balloon dilatation and successful stent delivery, resulting stent under-expansion, malposition, and damage to the drug-eluting polymer coats. This translates to poorer procedural outcomes and increased risk of Major Adverse Cardiovascular Events (MACE). The investigators' proposal seeks to determine the feasibility of the SoniCracker IVL in patients with calcified coronary lesions.
Detailed description
Coronary calcifications are one of the strongest predictors of adverse intraprocedural and long-term PCI outcomes. We believe SoniCraker IVL provides a safer and less aggressive method of calcium modification as opposed to traditional coronary atherectomy, hence translating into better clinical outcomes for patient. Although there is a commercially available IVL (Shockwave balloon) available, it is currently priced at ~ SGD 4000. The SoniCracker IVL is potentially a more cost-effective alternative to the Shockwave IVL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- At baseline, enrolled participants will be treated with the study device - SoniCracker Intravascular Lithotripsy Balloon during routine percutaneous coronary intervention (PCI). This device consists of a single-use, sterile catheter with multiple emitters mounted on a coronary balloon. The balloon is inserted into the coronary arteries. The emitters on the balloon then create shockwaves that cause cracks the calcium of the coronary arteries. The catheter is removed after the procedure. The rest of the PCI will be performed as per regular care. At 30 days post PCI procedure, participants will be followed up via telephone calls.
| Arm | Type | Receives |
|---|---|---|
| SoniCracker IVL | Experimental | Device: Medical device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients at age ≥ 21 years old.
- Patients undergoing elective/ planned PCI with at least moderate coronary calcification on angiography at the target lesion are eligible for enrolment. Moderate coronary calcification is defined as densities on only one side of the arterial wall prior to contrast injection. Severe calcification was defined as radiopacities on both sides of the arterial wall prior to contrast injection.
- Patients need to demonstrate evidence of either a 180 arc of coronary calcium or nodular calcium at the target lesion on intravascular imaging prior to IVL therapy.
Key exclusion criteria (9 listed)
- Significant co-morbidities:
- Patients requiring urgent or emergent PCI.
- Patients who are unable to provide consent.
- Patients who are pregnant.
- Breast-feeding women
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 |
|---|---|---|
| Medical deviceThe SoniCracker IVL is a rapid-exchange catheter with an effective length of 1420mm, with two radiopaque markers at the distal end and is coated with a hydrophilic coating from the distal tip to the wire exchange port to facilitate tracking and catheter delivery during use. The catheter lumen consists of a wire lumen, an inflation lumen, and two shockwave electrodes. The wire lumen allows passage of a 0.014" guidewire to guide the catheter into and through the lesion. The inflation lumen is filled with a 50%/50% mixture of physiological saline and contrast media to inflate and deflate the balloon. The electrode traverses the entire effective length of the catheter for lithotripsy treatment. The proximal end of the catheter features a hub with two ports, one for inflation/deflation of the balloon, and the other for connecting the electrode wires to the Coronary intravascular lithotripsy therapy device. | Device | SoniCracker IVL |
Primary outcome
Procedural success
Time frame: Perioperative
Successful delivery and deployment of the study device, and attainment of less than 50% diameter stenosis after stenting with no evidence of in-hospital major adverse cardiac events (MACE: cardiac death, myocardial infarction or target vessel revascularization)
1 secondary outcome
Device success (successful delivery and deployment of a device, and attainment of less than 50% diameter stenosis), 30-day MACE, coronary complications, post procedural angiographic and intravascular imaging outcomes
Time frame: Up to 30 days (+ 1 month) post PCI
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 2 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical device in people with Cardiovascular Diseases, run by National Heart Centre Singapore at 1 site in Singapore.
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 9 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: looking for participants now, as of the sponsor's last update on 2 Dec 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 Singapore. 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 Yann Shan Keh (+ 65 6704 8963, keh.yann.shan@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: Perioperative). 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 2 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.