Coronary Artery DiseaseNCT05101005
Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions
A study testing Drug-Coated Balloon and Sirolimus-Eluting Stent in people with Coronary Artery Disease and Drug-coated Balloon, run by Lepu Medical Technology (Beijing) Co., Ltd..
Trial summary
To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75~4.0mm). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Drug-coated Balloon
- What is being tested?
- Drug-Coated Balloon and Sirolimus-Eluting Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Nov 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
- Age ≥18 years and ≤80 years, regardless of gender;
- De novo lesion in a native coronary artery;
- Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia;
- Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1;
- The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting);
- The subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up.
Who cannot join
- Reference vessel diameter <2.75 mm or >4.0 mm;
- In stent restenosis;
- Left main lesion, chronic complete occlusion lesion;
- Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm;
- There is a large scale of thrombus in the target vessel, and the thrombus grade >3 after thrombolysis or aspiration;
- Severe heart failure (NYHA IV);
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- Severe renal failure (GFR<30ml/min) or undergoing hemodialysis treatment;
- Severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal);
- Patients with vein graft restenosis after bypass or severe heart valve disease;
- Pregnant or breastfeeding female patients;
- The life expectancy of the patient is less than 12 months;
- The subject cannot be treated with anticoagulation because of bleeding tendency, history of active peptic ulcer, stroke in the 6 months before surgery, anti-platelet agents or anticoagulant treatment contraindications;
- Anemia (women's hemoglobin <117g/L, or men's hemoglobin <134g/L), or thrombocytopenia detected before the intervention within 6 months (<100×10⁹/L);
- Planned to perform non-cardiac surgery within 12 months after index procedure;
- The subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint;
- Heart transplant patients;
- Allergic to aspirin, clopidogrel, heparin, contrast agents, or paclitaxel;
- The investigator judged that the patient had poor compliance and could not complete the study as required.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multi-center, Randomized Trial Comparing the Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions
To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75~4.0mm).
Read the detailed description
Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.
- Conditions
- Coronary Artery Disease, Drug-coated Balloon
- Being tested
- Drug-Coated Balloon, Sirolimus-Eluting Stent
- 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.
Drug-Coated BalloonDevice
Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions.
Sirolimus-Eluting StentDevice
Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions.
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon | Experimental | Drug-coated balloon is used to treat coronary artery stenosis lesions and improve myocardial blood flow. Receives: Device: Drug-Coated Balloon |
| Sirolimus-Eluting Stent | Active comparator | Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions. Receives: Device: Sirolimus-Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization
Measured: 12 months follow-up
Secondary outcomes (3)
Procedural success
Consisting of device success ( after successful delivery of the study balloon, the visual residual stenosis of the target lesion is less than 50%, TIMI level 3 blood flow ) , Lesion success (defined as the proportion of the target lesions in which the final stenosis is <20% after treatment with any other adjunctive therapy ) , Clinical success ( Defined as no major adverse cardiac events caused by ischemia during the subject's hospitalization).
Measured: During the hospital stay, up to 7 days after PCI
Target lesion failure
A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization
Measured: 1 month, 6months follow-up
Patient-oriented composite endpoint
A composite of all-cause mortality, myocardial infarction, and any revascularization
Measured: 1 month, 6months,12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yansong Li, Principal investigator, Shanghai Songjiang Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101005
- Sponsor's protocol ID
- SJDCB-01
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 29 Oct 2021
- Results posted
- 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 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Trial Comparing the Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions
- ClinicalTrials.gov ID
- NCT05101005
- Acronym / sponsor ID
- SJDCB-01
- Conditions
- Coronary Artery Disease, Drug-coated Balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 29 Oct 2021 (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 efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75~4.0mm).
Detailed description
Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon | Experimental | Device: Drug-Coated BalloonDrug-coated balloon is used to treat coronary artery stenosis lesions and improve myocardial blood flow. |
| Sirolimus-Eluting Stent | Active comparator | Device: Sirolimus-Eluting StentSirolimus-Eluting Stent is treated for coronary artery stenosis lesions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years and ≤80 years, regardless of gender;
- De novo lesion in a native coronary artery;
- Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia;
- Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1;
- The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting);
Key exclusion criteria (18 listed)
- Reference vessel diameter <2.75 mm or >4.0 mm;
- In stent restenosis;
- Left main lesion, chronic complete occlusion lesion;
- Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm;
- There is a large scale of thrombus in the target vessel, and the thrombus grade >3 after thrombolysis or aspiration;
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 |
|---|---|---|
| Drug-Coated BalloonDrug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions. | Device | Drug-coated balloon |
| Sirolimus-Eluting StentSirolimus-Eluting Stent is treated for coronary artery stenosis lesions. | Device | Sirolimus-Eluting Stent |
Primary outcome
Target lesion failure
Time frame: 12 months follow-up
A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization
3 secondary outcomes
Procedural success
Time frame: During the hospital stay, up to 7 days after PCI
Target lesion failure
Time frame: 1 month, 6months follow-up
Patient-oriented composite endpoint
Time frame: 1 month, 6months,12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- 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.
Yansong Li principal investigator
Shanghai Songjiang Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Drug-Coated Balloon and Sirolimus-Eluting Stent in people with Coronary Artery Disease and Drug-coated Balloon, run by Lepu Medical Technology (Beijing) Co., 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 6 inclusion and 18 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 29 Oct 2021. 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 Yansong Li (8618221277176, liyansong021@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 12 months follow-up). 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 29 Oct 2021.