Drug-coated BalloonSTENTLESSNCT06084000
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
A study testing Drug-coated balloon (Commercially available Paclitaxel-coated Balloon, China) and Drug-eluting stent in people with Drug-coated Balloon and Drug-eluting Stent, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This is a multicenter, open-label, randomized controlled study meant to compare the safety and efficacy of scheduled drug-coated balloon (DCB) and conventional drug-eluting stent (DES) strategy in the treatment of de novo lesions of large coronary vessel with diameter larger than 2.75 mm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-coated Balloon, Drug-eluting Stent, De Novo Stenosis
- What is being tested?
- Drug-coated balloon (Commercially available Paclitaxel-coated Balloon, China) and Drug-eluting stent
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,700 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2023to 15 Feb 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- De novo lesions of large coronary vessels with the diameter of target lesion reference vessel ≥ 2.75 mm
- Single- or multi-vessel disease with only 1 lesion meeting the definition of severe stenosis and anatomically amenable to coronary revascularization using DCB alone judged by physician.
- The prospective subject is agreed on participating the study with a formal written consent
Who cannot join
- Acute myocardial infarction* (STEMI or NSTEMI) within the past one month
- Diagnosis of myocardial infarction (MI) requires both clinical evidence of myocardial ischemia and elevation of cardiac Troponin (cTn) I or T values with at least 1 value above the 99th percentile upper normal range limit (URL)
- Clinical evidence of myocardial ischemia is defined as 1 of the following:
- Symptoms of myocardial ischemia
- New ischemic ECG changes
- Development of pathological Q waves
Show all 37Show fewer
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
- Identification of a coronary thrombus by angiography
- Type 1 MI defined by "the Fourth Universal Definition of Myocardial Infarction (2018)", which occurred within the last one month from inclusion phase would be excluded from this study.
- Patients who have received percutaneous coronary intervention (including stent implantation, plain old balloon angioplasty, and DCB angioplasty) within 12 months on the target vessel before the index procedure.
- Currently recommended indications for DCB: in-stent restenosis, complex bifurcation lesions requiring concomitant intervention of the major vessel and its adjacent side branch (e.g., lesions requiring dual stent implantation, kissing balloon technique, etc.)
- Lesions with any of the following anatomical characteristics presumably not suitable for DCB treatment:
- long lesion with length >= 40mm.
- severe tortuous, or severe angulated vessels, especially when vessel recoil seems possible.
- Chronic total occlusion
- Definition: A lesion of a coronary artery becomes completely blocked for a duration of greater than or equal to 3 months based on angiographic evidence.
- lesions in left main coronary artery
- lesions in venous or arterial graft
- Chronic heart failure with left ventricular ejection fraction < 35% after 6 months of Guideline-Directed Medical Treatment (GDMT)
- Acute heart failure, hemodynamic instability, or cardiogenic shock
- Acute heart failure is defined as a rapid onset of new or worsening signs and symptoms of heart failure.
- Non-cardiac Comorbidities:
- Severe liver insufficiency defined as 1 of the following:
- alanine transaminase or aspartate transaminase more than 5-fold of upper reference limit.
- Child-Pugh grade B or C.
- Severe renal insufficiency with estimated glomerular filtration rate < 30 ml/min/1.73m2.
- Malignant tumor.
- A life expectancy of less than 1 year.
- Unsuitable for coronary intervention or long-term antithrombotic therapy
- Myocardial bridging located at target lesions.
- Major bleeding (BARC type 3 to 5) or active pathological bleeding (including gastrointestinal or genitourinary bleeding) within 3 months, or major surgery within 2 months.
- Intolerable to double (aspirin plus P2Y12 inhibitor) or single (aspirin or P2Y12 inhibitor) antiplatelet therapy.
- History of intracranial hemorrhage.
- Pregnant women, lactating women, and women of childbearing potential.
- History of artificial valve replacement.
- History of participating in any other clinical studies or trials within 12 months before the index procedure.
- Participants deemed unsuitable to be enrolled by investigators, such as conditions that may result in protocol nonadherence.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
Beijing, 100037
About this study
This is a multicenter, open-label, randomized controlled study meant to compare the safety and efficacy of scheduled drug-coated balloon (DCB) and conventional drug-eluting stent (DES) strategy in the treatment of de novo lesions of large coronary vessel with diameter larger than 2.75 mm. The trial was designed to provide high-quality evidence for expanding the clinical indications of DCB, and to explore a better way for coronary intervention based on DCB.
- Conditions
- Drug-coated Balloon, Drug-eluting Stent, De Novo Stenosis
- Being tested
- Drug-coated balloon (Commercially available Paclitaxel-coated Balloon, China), Drug-eluting stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-coated balloon (Commercially available Paclitaxel-coated Balloon, China)Device
- Patients treated with DCB will receive dual antiplatelet therapy (DAPT, aspirin plus P2Y12 inhibitor) for 1-3 months, followed by long-term single antiplatelet therapy (SAPT, aspirin or P2Y12 inhibitor).
- Patients with bailout stenting will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see "special consideration" in Drug-eluting stent Arm), and then followed by long-term SAPT.
Drug-eluting stentDevice
- Patients treated with DES will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see "special consideration" below), and then followed by long-term SAPT.
- Special consideration:
- Patients will take additional assessment (both DAPT score and PRECISE-DAPT score) to determine their personalized duration of DAPT.
- The duration of DAPT is extended to 12 months for patients diagnosed as acute coronary syndrome within 12 months.
- If anticoagulation is indicated, patient will receive a short-term triple antithrombotic therapy (generally 1 to 4 weeks), followed by a variable length of dual antithrombotic therapy (oral anticoagulation (OAC) plus a single antiplatelet agent, preferably clopidogrel) and subsequent long-term OAC mono-therapy. The duration of dual antithrombotic therapy is determined by bleeding risks (HAS-BLED score) according to current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon dominant strategy | Experimental | * Patients will receive DCB (commercially available Paclitaxel-coated Balloon, China) only if pre-dilation of the lesion was successful, or otherwise receive bailout stenting.
* If bailout stenting is indicated, patients will receive any type of commercially available 2nd Gen DES at physician's preference. Receives: Device: Drug-coated balloon (Commercially available Paclitaxel-coated Balloon, China) |
| Drug-eluting stent only strategy | Active comparator | -For conventional stenting, patients will receive any type of commercially available 2nd Gen DES at physician's preference. Receives: Device: Drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
Measured: 12 months
Secondary outcomes (12)
Incidence of a composite of peri-procedural complications including cardiac death, perioperative myocardial infarction, acute thrombosis at target vessel and acute occlusion at target vessel
Incidence of a composite of peri-procedural complications including cardiac death, perioperative myocardial infarction, acute thrombosis at target vessel and acute occlusion at target vessel
Measured: 48 hours
Incidence of cardiac death
Incidence of cardiac death
Measured: 1, 12, 24, 36, and 60 months
Incidence of target-vessel myocardial infarction
Incidence of target-vessel myocardial infarction
Measured: 1, 12, 24, 36, and 60 months
Incidence of clinically indicated target lesion revascularization
Incidence of clinically indicated target lesion revascularization
Measured: 1, 12, 24, 36, and 60 months
Incidence of a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and re-hospitalization
Incidence of a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and re-hospitalization
Measured: 1, 12, 24, 36, and 60 months
Incidence of BARC (Bleeding Academic Research Consortium [BARC] definition, type 2 to 5)
Incidence of BARC (Bleeding Academic Research Consortium [BARC] definition, type 2 to 5)
Measured: 1, 12, 24, 36, and 60 months
Incidence of net clinical benefit (a composite of cardiac death, target-vessel myocardial infarction, clinically indicated target vessel revascularization and major bleeding)
Incidence of net clinical benefit (a composite of cardiac death, target-vessel myocardial infarction, clinically indicated target vessel revascularization and major bleeding (Bleeding type 3 or 5 according to the Bleeding ARC))
Measured: 1,12, 24, 36, and 60 months
Score of Seattle Angina Questionnaire (SAQ)
SAQ, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. SAQ scores range from 0 to 100 and higher scores indicate better health status.
Measured: 1, 12, 24, 36, and 60 months
Score of EuroQol Five Dimensions-5L (EQ-5D-5L)
The EQ-5D-5L questionnaires assesses health in five dimensions (Mobility, Human Autonomy, Current Activities, Pain / Discomfort, Anxiety / Depression), each of which has 5 levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). Health state index scores generally range from less than 0 to 1, with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale on which the patient rates his/her perceived health from 0 to 100.
Measured: 1, 12, 24, 36, and 60 months
Quality-adjusted life-years (QALYs)
Quality-adjusted life-years (QALYs)
Measured: 1, 12, 24, 36, and 60 months
Total costs
Total costs including the expenditure of hospitalization, physicians, examination, nursing care and medication
Measured: 12, 24, 36, and 60 months
Incremental cost-effectiveness ratios (ICER)
The ICER of scheduled DCB compared with conventional DES is defined as the ratio between incremental costs associated with scheduled DCB and the variation in effectiveness. Costs will be measured in Chinese yuan (RMB). Effectiveness will be considered both in terms of life years gained, measured in years, and in terms of quality of life gained, measured in QALY. In the first case, ICER will be measured as RMB/years; in the second, it will be measured as RMB/QALY.
Measured: 12, 24, 36, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start15 Oct 2023
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-coated BalloonStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- 2,700 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yongjian Wu, MD, PhD, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084000
- Sponsor's protocol ID
- 2023-I2M-1-002
- Acronym
- STENTLESS
- Status last verified
- May 2026
- First submitted
- 26 Sep 2023
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
- ClinicalTrials.gov ID
- NCT06084000
- Acronym / sponsor ID
- STENTLESS / 2023-I2M-1-002
- Conditions
- Drug-coated Balloon, Drug-eluting Stent, De Novo Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2031 (estimated)
- First posted
- 16 Oct 2023 (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 is a multicenter, open-label, randomized controlled study meant to compare the safety and efficacy of scheduled drug-coated balloon (DCB) and conventional drug-eluting stent (DES) strategy in the treatment of de novo lesions of large coronary vessel with diameter larger than 2.75 mm. The trial was designed to provide high-quality evidence for expanding the clinical indications of DCB, and to explore a better way for coronary intervention based on DCB.
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 dominant strategy | Experimental | Device: Drug-coated balloon (Commercially available Paclitaxel-coated Balloon, China)* Patients will receive DCB (commercially available Paclitaxel-coated Balloon, China) only if pre-dilation of the lesion was successful, or otherwise receive bailout stenting. * If bailout stenting is indicated, patients will receive any type of commercially available 2nd Gen DES at physician's preference. |
| Drug-eluting stent only strategy | Active comparator | Device: Drug-eluting stent-For conventional stenting, patients will receive any type of commercially available 2nd Gen DES at physician's preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- De novo lesions of large coronary vessels with the diameter of target lesion reference vessel ≥ 2.75 mm
- Single- or multi-vessel disease with only 1 lesion meeting the definition of severe stenosis and anatomically amenable to coronary revascularization using DCB alone judged by physician.
- The prospective subject is agreed on participating the study with a formal written consent
Key exclusion criteria (37 listed)
- Acute myocardial infarction* (STEMI or NSTEMI) within the past one month
- Patients who have received percutaneous coronary intervention (including stent implantation, plain old balloon angioplasty, and DCB angioplasty) within 12 months on the target vessel before the index procedure.
- Currently recommended indications for DCB: in-stent restenosis, complex bifurcation lesions requiring concomitant intervention of the major vessel and its adjacent side branch (e.g., lesions requiring dual stent implantation, kissing balloon technique, etc.)
- Lesions with any of the following anatomical characteristics presumably not suitable for DCB treatment:
- Chronic heart failure with left ventricular ejection fraction < 35% after 6 months of Guideline-Directed Medical Treatment (GDMT)
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 balloon (Commercially available Paclitaxel-coated Balloon, China)* Patients treated with DCB will receive dual antiplatelet therapy (DAPT, aspirin plus P2Y12 inhibitor) for 1-3 months, followed by long-term single antiplatelet therapy (SAPT, aspirin or P2Y12 inhibitor). * Patients with bailout stenting will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see "special consideration" in Drug-eluting stent Arm), and then followed by long-term SAPT. | Device | Drug-coated balloon dominant strategy |
| Drug-eluting stent* Patients treated with DES will generally receive DAPT for 6 months unless deemed as with high ischemic and/or bleeding risks (see "special consideration" below), and then followed by long-term SAPT. * Special consideration: 1. Patients will take additional assessment (both DAPT score and PRECISE-DAPT score) to determine their personalized duration of DAPT. 2. The duration of DAPT is extended to 12 months for patients diagnosed as acute coronary syndrome within 12 months. 3. If anticoagulation is indicated, patient will receive a short-term triple antithrombotic therapy (generally 1 to 4 weeks), followed by a variable length of dual antithrombotic therapy (oral anticoagulation (OAC) plus a single antiplatelet agent, preferably clopidogrel) and subsequent long-term OAC mono-therapy. The duration of dual antithrombotic therapy is determined by bleeding risks (HAS-BLED score) according to current guidelines. | Device | Drug-eluting stent only strategy |
Primary outcome
Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
Time frame: 12 months
Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
12 secondary outcomes
Incidence of a composite of peri-procedural complications including cardiac death, perioperative myocardial infarction, acute thrombosis at target vessel and acute occlusion at target vessel
Time frame: 48 hours
Incidence of cardiac death
Time frame: 1, 12, 24, 36, and 60 months
Incidence of target-vessel myocardial infarction
Time frame: 1, 12, 24, 36, and 60 months
Incidence of clinically indicated target lesion revascularization
Time frame: 1, 12, 24, 36, and 60 months
Incidence of a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and re-hospitalization
Time frame: 1, 12, 24, 36, and 60 months
Incidence of BARC (Bleeding Academic Research Consortium [BARC] definition, type 2 to 5)
Time frame: 1, 12, 24, 36, and 60 months
Incidence of net clinical benefit (a composite of cardiac death, target-vessel myocardial infarction, clinically indicated target vessel revascularization and major bleeding)
Time frame: 1,12, 24, 36, and 60 months
Score of Seattle Angina Questionnaire (SAQ)
Time frame: 1, 12, 24, 36, and 60 months
Score of EuroQol Five Dimensions-5L (EQ-5D-5L)
Time frame: 1, 12, 24, 36, and 60 months
Quality-adjusted life-years (QALYs)
Time frame: 1, 12, 24, 36, and 60 months
Total costs
Time frame: 12, 24, 36, and 60 months
Incremental cost-effectiveness ratios (ICER)
Time frame: 12, 24, 36, and 60 months
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 20 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-coated balloon (Commercially available Paclitaxel-coated Balloon, China) and Drug-eluting stent in people with Drug-coated Balloon and Drug-eluting Stent, run by China National Center for Cardiovascular Diseases at 1 site 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 4 inclusion and 37 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: under way, not looking for participants, as of the sponsor's last update on 20 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization (time frame: 12 months). 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 20 Oct 2026.