Coronary Artery DiseaseNCT06291545
Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Coronary Stenosis Lesions
A study testing Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） and ScoreFlex NC Coronary Dilatation Catheter in people with Coronary Artery Disease, run by JW Medical Systems Ltd.
Trial summary
This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. 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 scoring balloon dilation catheter（JW Medical Systems Ltd） and ScoreFlex NC Coronary Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2024to 30 Jun 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
- 1. Voluntary participation in this trial and signed the informed consent form;
- 2. Age: ≥18 and ≤80 years old, regardless of gender;
- 3. The existence of coronary artery stenosis lesions accompanied by evidence of ischemia in the heart (such as symptomatic coronary heart disease, stable/unstable angina pectoris or asymptomatic myocardial ischemia), suitable for percutaneous interventional therapy.
Who cannot join
- 1. Acute myocardial infarction (AMI) within 7 days before surgery;
- 2. Serum creatinine level >2.0 mg/dL (177 umol/L) within 7 days before surgery;
- 3. Active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery;
- 4. Stroke or transient ischemic attack (TIA) within 3 months before surgery;
- 5. Known left ventricular ejection fraction (LVEF) <30% (if LVEF is unknown, it can be measured during this surgery);
- 6. Known allergies to aspirin or heparin or the existence of contraindications that prevent the subjects from receiving sufficient preoperative medications;
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- 7. Known subjects allergic to ingredients in the test product or contrast agent;
- 8. Known subjects who are pregnant or breastfeeding;
- 9. Planned to use coronary atherectomy, laser ablation, other scoring / spiked / cutting balloons (non-study devices) or shock wave balloons to treat the target lesion at the same time;
- 10. Subjects participating in other drug or device clinical studies;
- 11. Other situations that are not suitable for participation in this study as assessed by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Design Clinical Trial, To Evaluate the Efficacy and Safety of the Coronary Artery Notched Balloon Dilation Catheter for the Pre-dilation of Coronary Artery Stenosis Lesions
This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery.
Read the detailed description
This trial uses a prospective, multicenter, randomized controlled, non-inferiority comparison design. It is expected that the test group will be non-inferior to the control group in the main effectiveness evaluation index (device success rate). This trial plans to enroll 200 subjects who meet the requirements, and they will be randomly assigned to the test group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up for 30 days after percutaneous coronary intervention (PCI) treatment to compare the test group and the control group in the main effectiveness evaluation index (device success rate), secondary effectiveness evaluation indices (immediate lumen gain [QCA analysis], surgical success rate, in-hospital major adverse cardiac event [MACE] incidence rate, target lesion failure [TLF] incidence rate within 30 days after surgery, patient-related composite endpoints [PoCE] incidence rate during and within 30 days after surgery, device operation and performance evaluation), and safety evaluation indices (device-related complication incidence rate, adverse event/serious adverse event incidence rate, device defect incidence rate), in order to evaluate the effectiveness and safety of the coronary scoring balloon dilation catheter of the test medical device.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd）, ScoreFlex NC Coronary Dilatation 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 scoring balloon dilation catheter（JW Medical Systems Ltd）Device
One hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the Coronary artery scoring balloon dilation catheter treatment group.
ScoreFlex NC Coronary Dilatation CatheterDevice
One hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the ScoreFlex NC Coronary Dilatation Catheter treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） | Experimental | Patients with Coronary Artery Disease will be treated with Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） Receives: Device: Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） |
| ScoreFlex NC Coronary Dilatation Catheter | Active comparator | Patients with Coronary Artery Disease will be treated with ScoreFlex NC Coronary Dilatation Catheter（OrbusNeich Medical [Netherlands] Ltd） Receives: Device: ScoreFlex NC Coronary Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful device usage
The investigational device was successfully delivered to the intended target lesion, dilated, deflated, and retrieved smoothly; After balloon angioplasty with the investigational device, the residual stenosis of the target lesion diameter was <50%.
Measured: 1hour
Secondary outcomes (4)
Rate of success of the surgery
The success of the surgery is defined as on the basis of successful use of the instrument, the residual stenosis of the target lesion diameter after PCI is ≤ 30% and TIMI blood flow is grade 3, and no MACE occurs in the hospital.
Measured: 3 days
Incidence of in-hospital MACE
MACE includes cardiac death, target vessel myocardial infarction, and target lesion re-vascularization
Measured: 30 days
Incidence of PoCE within 30 days after surgery
PoCE includes all-cause mortality, all MIs, and any re-vascularization
Measured: 30 days
The lumen is obtained immediately
The lumen is obtained immediately (QCA analysis)
Measured: 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start20 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Medical Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ling Tao, Ph.D, Principal investigator, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291545
- Sponsor's protocol ID
- JW-SBC202202
- Status last verified
- Jan 2024
- First submitted
- 19 Feb 2024
- Last updated
- 5 Mar 2024
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled, Non-inferiority Design Clinical Trial, To Evaluate the Efficacy and Safety of the Coronary Artery Notched Balloon Dilation Catheter for the Pre-dilation of Coronary Artery Stenosis Lesions
- ClinicalTrials.gov ID
- NCT06291545
- Acronym / sponsor ID
- JW-SBC202202
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- JW Medical Systems LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Mar 2024 (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 trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery.
Detailed description
This trial uses a prospective, multicenter, randomized controlled, non-inferiority comparison design. It is expected that the test group will be non-inferior to the control group in the main effectiveness evaluation index (device success rate). This trial plans to enroll 200 subjects who meet the requirements, and they will be randomly assigned to the test group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up for 30 days after percutaneous coronary intervention (PCI) treatment to compare the test group and the control group in the main effectiveness evaluation index (device success rate), secondary effectiveness evaluation indices (immediate lumen gain [QCA analysis], surgical success rate, in-hospital major adverse cardiac event [MACE] incidence rate, target lesion failure [TLF] incidence rate within 30 days after surgery, patient-related composite endpoints [PoCE] incidence rate during and within 30 days after surgery, device operation and performance evaluation), and safety evaluation indices (device-related complication incidence rate, adverse event/serious adverse event incidence rate, device defect incidence rate), in order to evaluate the effectiveness and safety of the coronary scoring balloon dilation catheter of the test medical 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 scoring balloon dilation catheter（JW Medical Systems Ltd） | Experimental | Device: Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd）Patients with Coronary Artery Disease will be treated with Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） |
| ScoreFlex NC Coronary Dilatation Catheter | Active comparator | Device: ScoreFlex NC Coronary Dilatation CatheterPatients with Coronary Artery Disease will be treated with ScoreFlex NC Coronary Dilatation Catheter（OrbusNeich Medical [Netherlands] Ltd） |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Voluntary participation in this trial and signed the informed consent form;
- 2. Age: ≥18 and ≤80 years old, regardless of gender;
- 3. The existence of coronary artery stenosis lesions accompanied by evidence of ischemia in the heart (such as symptomatic coronary heart disease, stable/unstable angina pectoris or asymptomatic myocardial ischemia), suitable for percutaneous interventional therapy.
Key exclusion criteria (11 listed)
- 1. Acute myocardial infarction (AMI) within 7 days before surgery;
- 2. Serum creatinine level >2.0 mg/dL (177 umol/L) within 7 days before surgery;
- 3. Active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery;
- 4. Stroke or transient ischemic attack (TIA) within 3 months before surgery;
- 5. Known left ventricular ejection fraction (LVEF) <30% (if LVEF is unknown, it can be measured during this surgery);
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 scoring balloon dilation catheter（JW Medical Systems Ltd）One hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the Coronary artery scoring balloon dilation catheter treatment group. | Device | Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） |
| ScoreFlex NC Coronary Dilatation CatheterOne hundred subjects who met the inclusion and exclusion criteria were enrolled and assigned to the ScoreFlex NC Coronary Dilatation Catheter treatment group. | Device | ScoreFlex NC Coronary Dilatation Catheter |
Primary outcome
Rate of successful device usage
Time frame: 1hour
The investigational device was successfully delivered to the intended target lesion, dilated, deflated, and retrieved smoothly; After balloon angioplasty with the investigational device, the residual stenosis of the target lesion diameter was <50%.
4 secondary outcomes
Rate of success of the surgery
Time frame: 3 days
Incidence of in-hospital MACE
Time frame: 30 days
Incidence of PoCE within 30 days after surgery
Time frame: 30 days
The lumen is obtained immediately
Time frame: 1hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- 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.
Ling Tao, Ph.D principal investigator
The First Affiliated Hospital of Air Force Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） and ScoreFlex NC Coronary Dilatation 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 3 inclusion and 11 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 5 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Wang, PM (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?
Rate of successful device usage (time frame: 1hour). 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 5 Mar 2024.