Patients With de Novo Coronary Artery LesionsNCT07582250
A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions
A study testing Biolimus-Coated Coronary Artery Balloon Dilatation Catheter and Xinyue Drug-Coated Stent System in people with Patients With de Novo Coronary Artery Lesions, run by JW Medical Systems Ltd.
Trial summary
To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients With de Novo Coronary Artery Lesions
- What is being tested?
- Biolimus-Coated Coronary Artery Balloon Dilatation Catheter and Xinyue Drug-Coated Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,548 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2030
- 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
General Inclusion Criteria:
- Patients aged ≥ 18 years and ≤ 80 years;
- Patients with stable angina, unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia with objective evidence;
- Patients without contraindications to coronary revascularization (PCI or CABG);
- Patients who can understand the study purpose, voluntarily participate in the trial, sign the informed consent form, and are willing to complete follow-up as required by the protocol.
Angiographic Inclusion Criteria:
- The target lesions are de novo native coronary artery lesions, located in 1 or 2 different coronary arteries; the number of target lesions in each coronary artery shall not exceed 1 (for two-vessel disease, a maximum of 2 target lesions are permitted).
- All target lesions shall meet the following requirements: ① The reference vessel diameter is between 2.25 mm and 4.0 mm, and the lesion length ≤ 30 mm; ② The visual estimated stenosis degree before procedure ≥ 70%, or ≥ 50% with documented ischemic evidence; ③ Successful pre-dilation: defined as no NHLBI type C or higher dissection; TIMI flow grade 3; residual stenosis ≤ 30%.
- Each target lesion is only allowed to be treated with one investigational device or control device (except for bailout stent implantation).
- If the patient has non-target lesions requiring concurrent intervention, such non-target lesions shall be successfully treated prior to the treatment of target lesions.
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
To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.
- Being tested
- Biolimus-Coated Coronary Artery Balloon Dilatation Catheter, Xinyue Drug-Coated Stent System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biolimus-Coated Coronary Artery Balloon Dilatation CatheterDevice
A total of 774 subjects meeting the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Biolimus-Coated Coronary Artery Balloon Dilatation Catheter.
Xinyue Drug-Coated Stent SystemDevice
A total of 774 eligible subjects who met the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Excrossal™ Xinyue Drug-Coated Stent System.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Biolimus-Coated Coronary Balloon Dilatation Catheter Receives: Device: Biolimus-Coated Coronary Artery Balloon Dilatation Catheter |
| Control Group | Active comparator | Xinyue Drug-Coated Stent System Receives: Device: Xinyue Drug-Coated Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
The primary endpoint of target lesion failure (TLF) at 1 year post-operation was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).
Measured: Day of procedure (treatment day), 7 days post-procedure or discharge day, 30 days post-procedure, 6 months post-procedure, 9 months post-procedure, and 1 year post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With de Novo Coronary Artery LesionsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Medical Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Liu, Principal investigator, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582250
- Sponsor's protocol ID
- JWBA9DES-202601
- Status last verified
- Apr 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT07582250
- Acronym / sponsor ID
- JWBA9DES-202601
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,548 participants (estimated)
- Lead sponsor
- JW Medical Systems LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 May 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.
To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Biolimus-Coated Coronary Artery Balloon Dilatation CatheterBiolimus-Coated Coronary Balloon Dilatation Catheter |
| Control Group | Active comparator | Device: Xinyue Drug-Coated Stent SystemXinyue Drug-Coated Stent System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Biolimus-Coated Coronary Artery Balloon Dilatation CatheterA total of 774 subjects meeting the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Biolimus-Coated Coronary Artery Balloon Dilatation Catheter. | Device | experimental group |
| Xinyue Drug-Coated Stent SystemA total of 774 eligible subjects who met the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Excrossal™ Xinyue Drug-Coated Stent System. | Device | Control Group |
Primary outcome
Primary endpoint
Time frame: Day of procedure (treatment day), 7 days post-procedure or discharge day, 30 days post-procedure, 6 months post-procedure, 9 months post-procedure, and 1 year post-procedure.
The primary endpoint of target lesion failure (TLF) at 1 year post-operation was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).
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 12 May 2026.
- Individual participant dataSharing planned: Yes
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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.
Bin Liu principal investigator
Second Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing Biolimus-Coated Coronary Artery Balloon Dilatation Catheter and Xinyue Drug-Coated Stent System in people with Patients With de Novo Coronary Artery Lesions, 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?
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 12 May 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 Wang Yang Project Manager (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?
Primary endpoint (time frame: Day of procedure (treatment day), 7 days post-procedure or discharge day, 30 days post-procedure, 6 months post-procedure, 9 months post-procedure, and 1 year post-procedure.). 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 12 May 2026.