Coronary Artery DiseaseNCT07140822
A Randomized Study of Cutting Balloon Catheter for CAD
A study testing Coronary Cutting Balloon Catheter and VesscideTM Cutting Balloon System in people with Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.
Trial summary
This study is designed as a prospective, multi-center, non-inferiority and randomized controlled clinical trial. A total of 158 eligible subjects from 18 sites across the country is planned to be enrolled, and they will be randomly assigned to the test group and the control group according to a ratio of 1:1 for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Calcified Coronary Lesions
- What is being tested?
- Coronary Cutting Balloon Catheter and VesscideTM Cutting Balloon System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2023to 10 Oct 2023
- 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
- Subjects aged 18-80 years, including 18 and 80 years;
- Patients with stable or unstable angina, or old myocardial infarction or clinically judged silent myocardial ischemia (target vessel reference vessel diameter 2.00-4.00 mm (both inclusive)), luminal diameter stenosis ≥ 70%, or ≥ 50% by visual inspection with evidence of ischemia, TIMI blood flow ≥ grade 1, and requiring treatment with a cutting balloon dilatation catheter as considered by the operator;
- Able to understand the purpose of the study, participate the study willingly, sign the written informed consent form, and are available for and willing to follow-up as defined in this trial.
- General exclusion criteria:
- Pregnant or lactating women or women who are planning pregnancy;
- Subjects with myocardial infarction occurred within one week; the myocardial enzyme TNI or TNT has not returned to normal although myocardial infarction has occurred for more than one week;
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- Subjects who are considered by the investigator through angiography that the cutting balloon cannot pass through even dilatation with a small one and need a rotational atherectomy;
- Non-target vessels, which can be treated simultaneously with the target blood vessel, have not been treated well in advance, or the total number of lesions on the non-target blood vessel is > 3;
- NYHA Class IV patients;
- Patients with severe renal failure (creatinine > 443 μmol/L) or ongoing hemodialysis therapy;
- Heart transplant patients;
- Patients with graft vessel disease;
- Patients with hemodynamic instability or symptoms of shock;
- Patients with a life expectancy of no more than 1 year;
- Patients who are expected to undergo elective surgery within 1 month;
- Patients not eligible for coronary artery bypass grafting (CABG) procedure;
- Patients with a predisposition to bleeding, a history of active peptic ulcer, or contraindications to antiplatelet agents and anticoagulants, patients who cannot undergo anticoagulant therapy, or patients who have experienced hemorrhagic stroke within 6 months;
- Patients who are known to be allergic or contraindicated to heparin, contrast agents, etc.;
- Patients who are suffering from diseases that can cause difficulties in treatment and evaluation;
- Patients who have been selected and have participated in trials with other drug or medical device but have not reached the time limit of the primary study endpoint;
- Clinicians expect that the risk of interventional surgery is extremely high or other cases that should be ruled out;
- Patients who, in the judgment of the investigator, are poor compliance with the therapy and are unable to complete the trial as required;
- Lesion related exclusion criteria:
- Left main lesion or lesion at a distance of ≤ 2 mm from the left main coronary artery;
- Patients with thrombosis suggested by angiography;
- Patients with a total occluded lesion and a TIMI flow grade 0;
- Coronary artery spasm (CAS) without organic stenosis;
- Left main lesion without protection from bypass grafts or collateral flow;
- In addition to the above contraindications, conditions diagnosed by the physician as unsuitable for the use of the device.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center, Non-inferiority and Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of the Coronary Cutting Balloon Catheter in the Treatment of Coronary Artery Disease (CAD)
This study is designed as a prospective, multi-center, non-inferiority and randomized controlled clinical trial. A total of 158 eligible subjects from 18 sites across the country is planned to be enrolled, and they will be randomly assigned to the test group and the control group according to a ratio of 1:1 for balloon dilatation for the treatment of coronary artery disease.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Calcified Coronary Lesions
- Being tested
- Coronary Cutting Balloon Catheter, VesscideTM Cutting Balloon System
- 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.
Coronary Cutting Balloon CatheterDevice
This product uses a pressure device to pressurize the balloon to expand it. The blades designed on the surface of the balloon produce a cutting effect on the vascular lesions, allowing it to better embed into the plaque.
VesscideTM Cutting Balloon SystemDevice
This product utilizes a pressure mechanism to inflate the balloon, causing it to expand. The blades on the balloon's surface create a cutting action on the vascular lesions, enabling the device to penetrate the plaque more effectively.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Cutting Balloon Catheter | Experimental | Not described Receives: Device: Coronary Cutting Balloon Catheter |
| VesscideTM Cutting Balloon System | Active comparator | Not described Receives: Device: VesscideTM Cutting Balloon System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute gain
The acute gain is defined as the difference in minimal lumen diameter (MLD) of the target lesions measured by quantitative coronary angiography (QCA) before and after the balloon dilatation using balloons from the test group/control group.
Measured: Before and after balloon dilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start26 Apr 2023
- Primary completion24 Jul 2023
- Study completion10 Oct 2023
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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140822
- Sponsor's protocol ID
- CCBP01
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 26 Aug 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Non-inferiority and Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of the Coronary Cutting Balloon Catheter in the Treatment of Coronary Artery Disease (CAD)
- ClinicalTrials.gov ID
- NCT07140822
- Acronym / sponsor ID
- CCBP01
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Calcified Coronary Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 26 Aug 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.
This study is designed as a prospective, multi-center, non-inferiority and randomized controlled clinical trial. A total of 158 eligible subjects from 18 sites across the country is planned to be enrolled, and they will be randomly assigned to the test group and the control group according to a ratio of 1:1 for balloon dilatation for the treatment of coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Cutting Balloon Catheter | Experimental | Device: Coronary Cutting Balloon Catheter |
| VesscideTM Cutting Balloon System | Active comparator | Device: VesscideTM Cutting Balloon System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Subjects aged 18-80 years, including 18 and 80 years;
- Patients with stable or unstable angina, or old myocardial infarction or clinically judged silent myocardial ischemia (target vessel reference vessel diameter 2.00-4.00 mm (both inclusive)), luminal diameter stenosis ≥ 70%, or ≥ 50% by visual inspection with evidence of ischemia, TIMI blood flow ≥ grade 1, and requiring treatment with a cutting balloon dilatation catheter as considered by the operator;
- Able to understand the purpose of the study, participate the study willingly, sign the written informed consent form, and are available for and willing to follow-up as defined in this trial.
- Pregnant or lactating women or women who are planning pregnancy;
- Subjects with myocardial infarction occurred within one week; the myocardial enzyme TNI or TNT has not returned to normal although myocardial infarction has occurred for more than one week;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Coronary Cutting Balloon CatheterThis product uses a pressure device to pressurize the balloon to expand it. The blades designed on the surface of the balloon produce a cutting effect on the vascular lesions, allowing it to better embed into the plaque. | Device | Coronary Cutting Balloon Catheter |
| VesscideTM Cutting Balloon SystemThis product utilizes a pressure mechanism to inflate the balloon, causing it to expand. The blades on the balloon's surface create a cutting action on the vascular lesions, enabling the device to penetrate the plaque more effectively. | Device | VesscideTM Cutting Balloon System |
Primary outcome
Acute gain
Time frame: Before and after balloon dilation
The acute gain is defined as the difference in minimal lumen diameter (MLD) of the target lesions measured by quantitative coronary angiography (QCA) before and after the balloon dilatation using balloons from the test group/control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Cutting Balloon Catheter and VesscideTM Cutting Balloon System in people with Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by Shanghai Shenqi 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 29 inclusion and 0 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: finished, as of the sponsor's last update on 26 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute gain (time frame: Before and after balloon dilation). 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 26 Aug 2025.