Coronary Artery DiseaseNCT06385067
Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
An observational study of Coronary Artery Disease, run by JW Medical Systems Ltd at 2 sites in China.
Trial summary
The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world. The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Biolimus Coated Coronary Artery Balloon Dilation Catheter
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 10 May 2024to 30 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;
Who may be able to join
- Age ≥ 18 years;
- Primary coronary artery stenosis with a vessel diameter of 2.0 mm to 2.75 mm;
- Patients with residual stenosis of ≤ 30 percent after pretreatment and ≤ type B dissection; Patients who voluntarily participate in and sign the informed consent form, and who are willing to undergo follow-up as required by the protocol.
Who cannot join
- Pregnant or lactating females;
- Patients with cardiogenic shock;
- Patients with severe congestive heart failure or severe heart failure with NYHA class IV;
- Patients with severe valvular heart disease;
- Patients with a life expectancy of less than 24 months or factors that make clinical follow-up difficult;
- Patients who are considered unsuitable for inclusion by the investigator for other reasons.
- Those who are known to be allergic to melcrolimus and contrast media.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First People's Hospital of Lanzhou
Lanzhou, Gansu
Doctor
- Recruiting
the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Professor Li Lang, Doctor, 0771-5356566
About this study
Official title: Prospective, International Multicenter Clinical Study Evaluating the Safety and Efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter (BioAscend) in the Treatment of Primary Coronary Artery Disease in the Real World
The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.
The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.
Read the detailed description
Study Design:
- Prospective, international multi-center clinical study;
- It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;
- In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis.
- Register and collect data using the EDC system;
- Enrollment method: competitive enrollment;
- Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.
- Conditions
- Coronary Artery Disease
- Being tested
- Biolimus Coated Coronary Artery Balloon Dilation 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.
Biolimus Coated Coronary Artery Balloon Dilation CatheterDevice
Patients with Coronary Artery Disease will be treated with Biolimus Coated Coronary Artery Balloon Dilation Catheter
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0 mm-2.75 mm regardless of the number of blood vessels, the length and number of treated lesions. Receives: Device: Biolimus Coated Coronary Artery Balloon Dilation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure rate (TLF)
Target lesion failure rate (TLF) at 12 months after surgery, including cardiogenic death, target vascular myocardial infarction, and clinically symptom-driven target lesion revascularization (CD-TLR)
Measured: 12 months after surgery
Secondary outcomes (5)
Interventional success rate
Including device success rate, pathogenic power and clinical success rate
Measured: Immediately after operation
Device-related cardiovascular clinical composite endpoint
Device-related cardiovascular clinical composite endpoints from postoperative to pre-discharge, day 30, month 6, month 12, and month 24, including cardiac death, target vessel myocardial infarction, and clinically symptom-driven target lesion revascularization (excluding elective interventional therapy)Device-related cardiovascular clinical composite endpoints from postoperative to pre-discharge, day 30, month 6, month 12, and month 24, including cardiac death, target vessel myocardial infarction, and clinically symptom-driven target lesion revascularization (excluding elective interventional therapy)
Measured: From postoperative to before discharge, day 30, month 6, month 12, month 24
Patient-related cardiovascular clinical composite endpoint
Patient-related cardiovascular clinical composite endpoints including all-cause mortality, all myocardial infarction, and any revascularization (excluding elective interventional therapy) from postoperative to pre-discharge, day 30, month 6, month 12, and month 24
Measured: From postoperative to before discharge, day 30, month 6, month 12, month 24
Major adverse cardiac events (MACEs)
Including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at postoperative to pre-discharge, day 30, month 6, month 12, and month 24.
Measured: From postoperative to before discharge, day 30, month 6, month 12, month 24
Incidence of thrombotic events as defined by ARC
Including identified, probable, and unexcluded thrombosis in the acute, subacute, and late periods acute, subacute, and late Defined, probable, and non-excluded thrombosis within the segment
Measured: From postoperative to before discharge, day 30, month 6, month 12, month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start10 May 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Medical Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lang Li, Principal investigator, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385067
- Sponsor's protocol ID
- JW-PM-DCB-2024
- Status last verified
- Nov 2025
- First submitted
- 23 Apr 2024
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, International Multicenter Clinical Study Evaluating the Safety and Efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter (BioAscend) in the Treatment of Primary Coronary Artery Disease in the Real World
- ClinicalTrials.gov ID
- NCT06385067
- Acronym / sponsor ID
- JW-PM-DCB-2024
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- JW Medical Systems LtdIndustry (pharma, biotech, devices)
- Study start
- 10 May 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 25 Apr 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.
The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.
The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.
Detailed description
Study Design:
- Prospective, international multi-center clinical study;
- It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;
- In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis.
- Register and collect data using the EDC system;
- Enrollment method: competitive enrollment;
- Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Device: Biolimus Coated Coronary Artery Balloon Dilation CatheterUse at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0 mm-2.75 mm regardless of the number of blood vessels, the length and number of treated lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Primary coronary artery stenosis with a vessel diameter of 2.0 mm to 2.75 mm;
- Patients with residual stenosis of ≤ 30 percent after pretreatment and ≤ type B dissection; Patients who voluntarily participate in and sign the informed consent form, and who are willing to undergo follow-up as required by the protocol.
Key exclusion criteria (7 listed)
- Pregnant or lactating females;
- Patients with cardiogenic shock;
- Patients with severe congestive heart failure or severe heart failure with NYHA class IV;
- Patients with severe valvular heart disease;
- Patients with a life expectancy of less than 24 months or factors that make clinical follow-up difficult;
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 Dilation CatheterPatients with Coronary Artery Disease will be treated with Biolimus Coated Coronary Artery Balloon Dilation Catheter | Device | Experimental group |
Primary outcome
Target lesion failure rate (TLF)
Time frame: 12 months after surgery
Target lesion failure rate (TLF) at 12 months after surgery, including cardiogenic death, target vascular myocardial infarction, and clinically symptom-driven target lesion revascularization (CD-TLR)
5 secondary outcomes
Interventional success rate
Time frame: Immediately after operation
Device-related cardiovascular clinical composite endpoint
Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24
Patient-related cardiovascular clinical composite endpoint
Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24
Major adverse cardiac events (MACEs)
Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24
Incidence of thrombotic events as defined by ARC
Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24
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 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Lang Li principal investigator
First Affiliated Hospital of Guangxi Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by JW Medical Systems Ltd at 2 sites 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 3 inclusion and 7 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Yuanchun Sun (13683382463, sunyuanchun@bluesail.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure rate (TLF) (time frame: 12 months after surgery). 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 27 Oct 2026.