Coronary Artery DiseaseNCT06926400
The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in the Pre-dilation of Coronary Artery Stenosis Lesions
A study testing Coronary artery sawtooth cutting balloon dilation catheter and Cutting balloon catheter in people with Coronary Artery Disease, run by JW Medical Systems Ltd.
Trial summary
To evaluate the effectiveness and safety of the coronary serrated cutting balloon dilation catheter for the pre-dilation of coronary artery stenosis lesions. 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?
- Coronary artery sawtooth cutting balloon dilation catheter and Cutting balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 30 Mar 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
- ① The age is between 18 and 80 years old (including the boundary values), and the subjects are male or non-pregnant female.
- Have single or multiple coronary artery lesions and diagnosed ischemic heart disease (for example: stable angina pectoris, unstable angina pectoris, old myocardial infarction or asymptomatic myocardial ischemia).
- There are coronary artery stenosis lesions confirmed by coronary angiography, which are suitable for percutaneous coronary intervention. The coronary artery stenosis is ≥ 70% (by visual estimation); or ≥ 50% (by visual estimation) and accompanied by evidence of ischemia, and the TIMI blood flow is ≥ Grade 1.
- There are de novo or restenosis lesions in the coronary arteries of autologous or bypass graft vessels, and interventional treatment is required.
- The visually estimated reference vessel diameter of the target lesion is 2.0mm - 4.0mm, and the lesion length is ≤ 20mm.
- When there are multiple lesions that need to be treated, only one coronary artery lesion is selected as the target lesion, and the non-target lesions must be located on different vascular branches.
- Be able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and be able to and willing to accept the follow-up as specified in this trial.
Who cannot join
- General Exclusion Criteria
- Patients with New York Heart Association (NYHA) Class IV heart failure.
- Patients with contraindications to anti - platelet and anticoagulant therapy and are unable to receive anticoagulant treatment.
- Patients who have had any myocardial infarction within one week.
- Patients with an allergic reaction to contrast agents. ⑤ Patients with severe renal failure, with a serum creatinine level > 2.0 mg/dl (177 μmol/L).
- Patients who have undergone heart transplantation.
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- Patients who have had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery.
- ⑧ Patients who have had a stroke or transient ischemic attack within 3 months before surgery.
- Pregnant or lactating patients. ⑩ Patients who are currently participating in any other clinical trials. ⑪ Patients whom the investigator deems unsuitable for enrollment. Exclusion Criteria Related to the Target Lesion (Detected by Coronary Angiography)
- Tortuous lesions or lesions with an angulation of ≥ 45 degrees at the lesion site.
- Lesions at the ostium with a distance of ≤ 2 mm from the left main coronary artery.
- Unprotected left main coronary artery lesions. ④ Coronary angiography shows the presence of thrombus. ⑤ Before using the test device or the control device, the target lesion has a dissection of Type C or higher.
- Target lesions that require treatment with coronary atherectomy or special balloons (such as scored balloons, spiked balloons, shock - wave lithotripsy systems, and cutting balloons of other brands).
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: A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter for the Predilation of Coronary Artery Stenosis Lesions
To evaluate the effectiveness and safety of the coronary serrated cutting balloon dilation catheter for the pre-dilation of coronary artery stenosis lesions.
Read the detailed description
This study is a prospective, multicenter, randomized controlled, non-inferiority designed clinical trial. It is planned to enroll a total of 182 eligible subjects from multiple research centers. The subjects will be randomly assigned to the experimental group (n = 91) and the control group (n = 91) in a 1:1 ratio. All subjects will undergo immediate coronary angiography after percutaneous transluminal coronary angioplasty (PTCA) to evaluate the success rate of the device.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary artery sawtooth cutting balloon dilation catheter, Cutting balloon 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.
Coronary artery sawtooth cutting balloon dilation catheterDevice
Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a coronary artery sawtooth cutting balloon dilation catheter.
Cutting balloon catheterDevice
Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a cutting balloon catheter.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Serrated Cutting Balloon Dilatation Catheter (Shandong JW Medical Products Co., Ltd. | Experimental | Not described Receives: Device: Coronary artery sawtooth cutting balloon dilation catheter |
| Cutting Balloon Catheter | Active comparator | Not described Receives: Device: Cutting balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Procedural Success Rate
Measured: one hour
Secondary outcomes (9)
Clinical treatment success rate
Measured: one hour
acute lumen gain,ALG
Immediate lumen gain is defined as: ALG = the immediate minimum lumen diameter after balloon dilation - the minimum lumen diameter before the operation.
Measured: one hour
The incidence of the composite endpoint of target lesion failure (TLF) within 30 days after surgery
Measured: 30 days
The incidence of patient-related cardiovascular clinical composite endpoint (POCE) within 30 days after surgery
Measured: 30 days
The incidence of major adverse cardiac events (MACE) within 30 days after surgery
Measured: 30 days
Evaluation of Device Performance
CRF
Measured: one hour
The incidence rate of medical device-related complications
Measured: one hour
The incidence rate of device defects
Measured: one hour
The incidence rate of adverse events and serious adverse events
Measured: thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 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
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Medical Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Bo, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926400
- Sponsor's protocol ID
- JW-SEBC202412
- Status last verified
- Jan 2025
- First submitted
- 1 Apr 2025
- Last updated
- 13 Apr 2025
- 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 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter for the Predilation of Coronary Artery Stenosis Lesions
- ClinicalTrials.gov ID
- NCT06926400
- Acronym / sponsor ID
- JW-SEBC202412
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- JW Medical Systems LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 13 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.
To evaluate the effectiveness and safety of the coronary serrated cutting balloon dilation catheter for the pre-dilation of coronary artery stenosis lesions.
Detailed description
This study is a prospective, multicenter, randomized controlled, non-inferiority designed clinical trial. It is planned to enroll a total of 182 eligible subjects from multiple research centers. The subjects will be randomly assigned to the experimental group (n = 91) and the control group (n = 91) in a 1:1 ratio. All subjects will undergo immediate coronary angiography after percutaneous transluminal coronary angioplasty (PTCA) to evaluate the success rate of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Serrated Cutting Balloon Dilatation Catheter (Shandong JW Medical Products Co., Ltd. | Experimental | Device: Coronary artery sawtooth cutting balloon dilation catheter |
| Cutting Balloon Catheter | Active comparator | Device: Cutting balloon catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ① The age is between 18 and 80 years old (including the boundary values), and the subjects are male or non-pregnant female.
- Be able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and be able to and willing to accept the follow-up as specified in this trial.
Key exclusion criteria (13 listed)
- General Exclusion Criteria
- ⑧ Patients who have had a stroke or transient ischemic attack within 3 months before surgery.
- Target lesions that require treatment with coronary atherectomy or special balloons (such as scored balloons, spiked balloons, shock - wave lithotripsy systems, and cutting balloons of other brands).
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 artery sawtooth cutting balloon dilation catheterNinety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a coronary artery sawtooth cutting balloon dilation catheter. | Device | Coronary Artery Serrated Cutting Balloon Dilatation Catheter (Shandong JW Medical Products Co., Ltd. |
| Cutting balloon catheterNinety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a cutting balloon catheter. | Device | Cutting Balloon Catheter |
Primary outcome
Device Procedural Success Rate
Time frame: one hour
9 secondary outcomes
Clinical treatment success rate
Time frame: one hour
acute lumen gain,ALG
Time frame: one hour
The incidence of the composite endpoint of target lesion failure (TLF) within 30 days after surgery
Time frame: 30 days
The incidence of patient-related cardiovascular clinical composite endpoint (POCE) within 30 days after surgery
Time frame: 30 days
The incidence of major adverse cardiac events (MACE) within 30 days after surgery
Time frame: 30 days
Evaluation of Device Performance
Time frame: one hour
The incidence rate of medical device-related complications
Time frame: one hour
The incidence rate of device defects
Time frame: one hour
The incidence rate of adverse events and serious adverse events
Time frame: thirty days
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 13 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.
Yu Bo principal investigator
The Second Affiliated Hospital of Harbin Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Coronary artery sawtooth cutting balloon dilation catheter and Cutting balloon catheter in people with Coronary Artery Disease, run by JW Medical Systems 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 7 inclusion and 13 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 13 Apr 2025. 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 WangYang (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?
Device Procedural Success Rate (time frame: one hour). 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 13 Apr 2025.