ST-elevation Myocardial Infarction (STEMI)DCB-STEMINCT06742125
Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With ST-Segment Elevation Myocardial Infarction
A study testing Drug-coated balloon (DCB) and Drug-eluting stent (DES) in people with ST-elevation Myocardial Infarction (STEMI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Acute ST-segment elevation myocardial infarction (STEMI) is a life-threatening emergency requiring immediate intervention. The incidence of premature coronary artery disease (PCAD) is rising rapidly in China; its long-term prognosis remains poor and it frequently progresses to acute myocardial infarction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-elevation Myocardial Infarction (STEMI)
- What is being tested?
- Drug-coated balloon (DCB) and Drug-eluting stent (DES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,244 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2025to 1 Jan 2032
- 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 of Patients ≥18 years old;
- Acute myocardial infarction patients with onset symptoms<48 hours require emergency PCI;
- . Diagnosis: Chest pain and other ischemic symptoms accompanied by ST segment elevation in at least two adjacent leads on electrocardiogram (① V2 or V3 lead: male<40 years ≥ 0.25mV, ≥ 40 years ≥ 0.2mV; Female ≥1.5mV；② Other leads ≥ 1mV), or new left bundle branch block occurs;
- Criminal blood vessels with clear requirements for emergency PCI;
- Coronary artery in situ lesions, with a visual reference lumen diameter of ≥ 2mm and ≤ 4mm; Lesion's length<40mm；
- After thrombus aspiration and pre dilation, the lesion stenosis is ≤ 50% and there is no C-type or above dissection.
- He/she or his/her legal representative voluntarily participates in this study and signs an informed consent form.
Who cannot join
- The patient has allergies or contraindications to the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Cilostazol, Indobufen, Contrast Medias (Patients with clear contrast agent allergies such as rash but can be controlled with effective drugs such as glucocorticoids and diphenhydramine in advance can be selected);
- The patient has active pathological bleeding;
- History of significant gastrointestinal or urogenital bleeding or bleeding tendency within 3 months prior to surgery, known coagulation disorders (including heparin induced thrombocytopenia);
- Patients who are pregnant or have the intention to become pregnant during the period of research;
- Non cardiogenic combined lesions show an expected life expectancy of less than one year;
- Left main trunk's stenosis ≥ 50%
Show all 10Show fewer
- History of coronary artery bypass grafting in the past;
- Intubation or mechanical ventilation status;
- . Cardiogenic Shock
- . Without signature on informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Chi Liu, +8615950550839, liuchi1011@163.com
About this study
Acute ST-segment elevation myocardial infarction (STEMI) is a life-threatening emergency requiring immediate intervention. The incidence of premature coronary artery disease (PCAD) is rising rapidly in China; its long-term prognosis remains poor and it frequently progresses to acute myocardial infarction, necessitating high-risk therapies such as primary percutaneous coronary intervention (PCI) or coronary artery bypass grafting, thereby imposing enormous economic and psychological burdens on patients and their families. Moreover, the cumulative 6-year rate of death or myocardial infarction after implantation of the latest-generation drug-eluting stents still reaches 15%, and management of stent failure is extremely challenging. Drug-coated balloon (DCB) angioplasty-representing the "leave-nothing-behind" paradigm-is a highly promising option in young subjects. Accumulating clinical evidence demonstrates that DCB provides favorable efficacy across a broad spectrum of lesions, including small-vessel and large-vessel de novo disease, bifurcation lesions, and in-stent restenosis. Nevertheless, high-quality data on the impact of DCB angioplasty in de novo large-vessel disease and in the setting of acute STEMI are still lacking.
Read the detailed description
Objectives of Study:
Compare the clinical outcomes of drug-coated balloon (DCB) and drug-eluting stent (DES) treatment in patients with ST-segment elevation myocardial infarction (STEMI).
Design of Study:
Investigator-Initiated，Open Label，Prospective，Multicenter，Randomized Clinical Trial.
Patients Selected： This study aims to STEMI patients who have successfully completed lesion pretreatment in multiple medical centers in China. Patients who meet the inclusion criteria and have no exclusion criteria will be randomly assigned 1:1 to the drug coated balloon group and drug eluting stent group, totaling 1244 cases (622 cases per group).
- Being tested
- Drug-coated balloon (DCB), Drug-eluting stent (DES)
- Keywords
- Drug-coated balloon, Drug-eluting stent, ST-elevation myocardial infarction (STEMI)
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-coated balloon (DCB)Device
Drug-coated balloon treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.
Drug-eluting stent (DES)Device
Drug-eluting stent treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| DCB group | Experimental | STEMI patients undergo revascularization using DCB Receives: Device: Drug-coated balloon (DCB) |
| DES group | Active comparator | STEMI patients undergo revascularization using DES Receives: Device: Drug-eluting stent (DES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)
POCE including all-cause mortality, any stroke, any myocardial infarction (MI), and any revascularization, will be obtained through follow-up of subjects.
Measured: 12 months
Secondary outcomes (13)
Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)
POCE including all-cause mortality, any stroke, any myocardial infarction (MI), and any revascularization, will be obtained through follow-up of subjects.
Measured: 36 months, 60 months
Incidence of target vessel failure (Direct measurement and coronary angiography)
Target vessel failure (a composite of cardiac death, target-vessel MI, or target vessel revascularization) will be obtained through follow-up of subjects.
Measured: 12 months
Incidence of all-cause mortality (Direct measurement)
All-cause mortality will be obtained through follow-up of subjects.
Measured: 36 months, 60 months
Incidence of non-fatal MI (Direct measurement)
Non-fatal MI will be obtained through follow-up of subjects.
Measured: 36 months, 60 months
Incidence of any revascularization (coronary angiography)
Any revascularization will be obtained through follow-up of subjects.
Measured: 36 months, 60 months
Incidence of all-cause and cardiac death (Direct measurement)
All-cause and cardiac death will be obtained through follow-up of subjects.
Measured: 12 months, 36 months, 60 months
Incidence of any non-fatal MI without peri-procedural MI (Direct measurement)
Any non-fatal MI without peri-procedural MI will be obtained through follow-up of subjects.
Measured: 12 months, 36 months, 60 months
Incidence of any non-fatal MI with peri-procedural MI (Direct measurement)
Any non-fatal MI with peri-procedural MI will be obtained through follow-up of subjects.
Measured: 12 months, 36 months, 60 months
Incidence of any target vessel/lesion revascularization (Coronary angiography)
Any target vessel/lesion revascularization will be obtained through follow-up of subjects.
Measured: 12 months, 36 months, 60 months
Incidence of any non-target vessel/lesion revascularization (Coronary angiography)
Any non-target vessel/lesion revascularization will be obtained through follow-up of subjects.
Measured: 12 months, 36 months, 60 months
Incidence of any revascularization (ischemia-driven or all) (Coronary angiography)
Any revascularization (ischemia-driven or all) will be obtained through follow-up of subjects.
Measured: 12 months, 36 months, 60 months
Incidence of non-fatal stroke (ischemic and hemorrhagic) (Direct measurement)
Non-fatal stroke (ischemic and hemorrhagic) will be obtained through follow-up of subjects.
Measured: 12 months, 36 months, 60 months
CRP and POCE
Prognostic value of CRP on POCE
Measured: 12 months, 36 months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start31 May 2025
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 1,244 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Peking University First Hospital, Suzhou Municipal Hospital, First Affiliated Hospital of Ningbo University
- Responsible party
- Sponsor
- Investigators
- Jun Jiang, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742125
- Sponsor's protocol ID
- 2024-0936
- Acronym
- DCB-STEMI
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2024
- Last updated
- 28 Sep 2026
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With ST-Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06742125
- Acronym / sponsor ID
- DCB-STEMI / 2024-0936
- Keywords
- Drug-coated balloon, Drug-eluting stent, ST-elevation myocardial infarction (STEMI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,244 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Peking University First Hospital, Suzhou Municipal Hospital, First Affiliated Hospital of Ningbo University
- Study start
- 31 May 2025 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 19 Dec 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.
Acute ST-segment elevation myocardial infarction (STEMI) is a life-threatening emergency requiring immediate intervention. The incidence of premature coronary artery disease (PCAD) is rising rapidly in China; its long-term prognosis remains poor and it frequently progresses to acute myocardial infarction, necessitating high-risk therapies such as primary percutaneous coronary intervention (PCI) or coronary artery bypass grafting, thereby imposing enormous economic and psychological burdens on patients and their families. Moreover, the cumulative 6-year rate of death or myocardial infarction after implantation of the latest-generation drug-eluting stents still reaches 15%, and management of stent failure is extremely challenging. Drug-coated balloon (DCB) angioplasty-representing the "leave-nothing-behind" paradigm-is a highly promising option in young subjects. Accumulating clinical evidence demonstrates that DCB provides favorable efficacy across a broad spectrum of lesions, including small-vessel and large-vessel de novo disease, bifurcation lesions, and in-stent restenosis. Nevertheless, high-quality data on the impact of DCB angioplasty in de novo large-vessel disease and in the setting of acute STEMI are still lacking.
Detailed description
Objectives of Study:
Compare the clinical outcomes of drug-coated balloon (DCB) and drug-eluting stent (DES) treatment in patients with ST-segment elevation myocardial infarction (STEMI).
Design of Study:
Investigator-Initiated，Open Label，Prospective，Multicenter，Randomized Clinical Trial.
Patients Selected： This study aims to STEMI patients who have successfully completed lesion pretreatment in multiple medical centers in China. Patients who meet the inclusion criteria and have no exclusion criteria will be randomly assigned 1:1 to the drug coated balloon group and drug eluting stent group, totaling 1244 cases (622 cases per group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB group | Experimental | Device: Drug-coated balloon (DCB)STEMI patients undergo revascularization using DCB |
| DES group | Active comparator | Device: Drug-eluting stent (DES)STEMI patients undergo revascularization using DES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- . Age of Patients ≥18 years old;
- Acute myocardial infarction patients with onset symptoms<48 hours require emergency PCI;
- . Diagnosis: Chest pain and other ischemic symptoms accompanied by ST segment elevation in at least two adjacent leads on electrocardiogram (① V2 or V3 lead: male<40 years ≥ 0.25mV, ≥ 40 years ≥ 0.2mV; Female ≥1.5mV；② Other leads ≥ 1mV), or new left bundle branch block occurs;
- Criminal blood vessels with clear requirements for emergency PCI;
- Coronary artery in situ lesions, with a visual reference lumen diameter of ≥ 2mm and ≤ 4mm; Lesion's length<40mm；
Key exclusion criteria (10 listed)
- The patient has allergies or contraindications to the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Cilostazol, Indobufen, Contrast Medias (Patients with clear contrast agent allergies such as rash but can be controlled with effective drugs such as glucocorticoids and diphenhydramine in advance can be selected);
- The patient has active pathological bleeding;
- History of significant gastrointestinal or urogenital bleeding or bleeding tendency within 3 months prior to surgery, known coagulation disorders (including heparin induced thrombocytopenia);
- Patients who are pregnant or have the intention to become pregnant during the period of research;
- Non cardiogenic combined lesions show an expected life expectancy of less than one year;
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 (DCB)Drug-coated balloon treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention. | Device | DCB group |
| Drug-eluting stent (DES)Drug-eluting stent treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention. | Device | DES group |
Primary outcome
Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)
Time frame: 12 months
POCE including all-cause mortality, any stroke, any myocardial infarction (MI), and any revascularization, will be obtained through follow-up of subjects.
13 secondary outcomes
Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)
Time frame: 36 months, 60 months
Incidence of target vessel failure (Direct measurement and coronary angiography)
Time frame: 12 months
Incidence of all-cause mortality (Direct measurement)
Time frame: 36 months, 60 months
Incidence of non-fatal MI (Direct measurement)
Time frame: 36 months, 60 months
Incidence of any revascularization (coronary angiography)
Time frame: 36 months, 60 months
Incidence of all-cause and cardiac death (Direct measurement)
Time frame: 12 months, 36 months, 60 months
Incidence of any non-fatal MI without peri-procedural MI (Direct measurement)
Time frame: 12 months, 36 months, 60 months
Incidence of any non-fatal MI with peri-procedural MI (Direct measurement)
Time frame: 12 months, 36 months, 60 months
Incidence of any target vessel/lesion revascularization (Coronary angiography)
Time frame: 12 months, 36 months, 60 months
Incidence of any non-target vessel/lesion revascularization (Coronary angiography)
Time frame: 12 months, 36 months, 60 months
Incidence of any revascularization (ischemia-driven or all) (Coronary angiography)
Time frame: 12 months, 36 months, 60 months
Incidence of non-fatal stroke (ischemic and hemorrhagic) (Direct measurement)
Time frame: 12 months, 36 months, 60 months
CRP and POCE
Time frame: 12 months, 36 months, 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 28 Sep 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.
Jun Jiang study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 (DCB) and Drug-eluting stent (DES) in people with ST-elevation Myocardial Infarction (STEMI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 10 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 28 Sep 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?
Contact Jucheng Zhang (+8618768146640, jucheng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography) (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 28 Sep 2026.