ST Elevation Myocardial Infarction (STEMI)STEMI-DCBNCT07806370
A Single-Center, Retrospective, Propensity-Score-Matched Cohort Study Comparing Drug-Coated Balloon Versus Drug-Eluting Stent for Reducing Immediate Post-Procedural Slow-Flow/No-Reflow in Acute ST-Elevation Myocardial Infarction Patients With High Thrombus Burden
An observational study of ST Elevation Myocardial Infarction (STEMI) and Acute Coronary Syndromes (ACS), run by Xijing Hospital at 1 site in China.
Trial summary
This is a single-center, retrospective, propensity-score-matched observational study. It aims to compare the rate of immediate slow-flow or no-reflow after percutaneous coronary intervention (PCI) between drug-coated balloon (DCB) and drug-eluting stent (DES) in STEMI patients with high thrombus burden. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST Elevation Myocardial Infarction (STEMI), Acute Coronary Syndromes (ACS)
- What is being tested?
- Drug-Coated Balloon (DCB) and Drug-Eluting Stent (DES)
- Type of treatment
- Medical device
- How many people
- 668 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Jan 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a single-center retrospective observational study. The study population consists of patients diagnosed with ST-elevation myocardial infarction (STEMI) with high thrombus burden (angiographic thrombus grade G2-G4) who underwent emergency percutaneous coronary intervention (PCI) at Xijing Hospital between January 1, 2019 and June 30, 2025. Eligible patients received either drug-coated balloon (DCB) or drug-eluting stent (DES) as the final revascularization strategy for the culprit vessel. Patients are identified from in-hospital medical records and coronary angiographic databases.
Who may be able to join
- Patients diagnosed with ST-elevation myocardial infarction (STEMI) undergoing emergency percutaneous coronary intervention (PCI) at this center:
- Symptom onset ≤ 12 hours; OR
- Symptom onset > 12 hours with persistent ischemic symptoms.
- Angiographic thrombus grade of the culprit vessel is G2-G4.
- Reference vessel diameter of the culprit vessel: 2.25-4.0 mm.
- Complete pre-procedural and post-procedural coronary angiographic imaging data are available.
- Age ≥ 18 years old.
Who cannot join
- Participation in other clinical trials.
- Cardiogenic shock or post-cardiac-arrest resuscitation state.
- Multi-vessel coronary artery disease.
- Severe calcified lesions requiring rotational atherectomy or shock-wave therapy.
- Only compliant or non-compliant plain balloon dilation performed.
- Both DES and DCB applied to the same culprit vessel.
- Culprit lesion located in a coronary bypass graft, or in-stent restenosis / in-stent thrombosis.
- Missing key angiographic or clinical follow-up data.
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
First Affiliated Hospital of Fourth Military Medical University
Xi'an, Shaanxi, 710032
Yuan He, MD, PhD, +86-13991854483, heyuan820927@163.com
About this study
Official title: Comparison Of Drug-Coated Balloon Versus Drug-Eluting Stent In STEMI Patients With High Thrombus Burden: A Single-Center Retrospective Study Using Propensity Score Matching
This is a single-center, retrospective, propensity-score-matched observational study. It aims to compare the rate of immediate slow-flow or no-reflow after percutaneous coronary intervention (PCI) between drug-coated balloon (DCB) and drug-eluting stent (DES) in STEMI patients with high thrombus burden. Medical records of eligible patients admitted between January 1, 2019 and June 30, 2025 will be reviewed. Propensity-score matching will be used to balance baseline characteristics of the two groups. Both procedural-related outcomes and 1-year clinical follow-up events will be analyzed.
- Being tested
- Drug-Coated Balloon (DCB), Drug-Eluting Stent (DES)
- Keywords
- High thrombus burden, Drug-coated balloon, Drug-eluting stent
- Medical subject headings
- ST Elevation Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Coated Balloon (DCB)Device
A drug-coated balloon catheter used for percutaneous coronary intervention in patients with STEMI and high thrombus burden. The balloon surface is coated with an antiproliferative drug (e.g., paclitaxel) that is transferred to the vessel wall during balloon inflation, inhibiting neointimal hyperplasia. No permanent metal scaffold is implanted after DCB-only revascularization.
Drug-Eluting Stent (DES)Device
A permanent coronary metal scaffold coated with an antiproliferative drug (e.g., sirolimus, everolimus, zotarolimus, or biolimus) implanted during percutaneous coronary intervention. The stent maintains vessel patency and the eluted drug inhibits neointimal hyperplasia. Used for culprit-vessel revascularization in STEMI patients with high thrombus burden, including bailout DES implantation after DCB predilation.
| Study group | Role | What they receive |
|---|---|---|
| Drug-Coated Balloon (DCB) Cohort | STEMI patients with high thrombus burden who received drug-coated balloon (DCB) as the final revascularization strategy for culprit coronary vessel Receives: Device: Drug-Coated Balloon (DCB) | |
| Drug-Eluting Stent (DES) Cohort | STEMI patients with high thrombus burden who received drug-eluting stent (DES) implantation as the final revascularization strategy for culprit coronary vessel, including bailout DES implantation after DCB. 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 immediate slow-flow or no-reflow after PCI
The incidence of immediate slow-flow or no-reflow phenomenon after percutaneous coronary intervention (PCI) with either drug-coated balloon (DCB) or drug-eluting stent (DES). Slow-flow/no-reflow is defined as TIMI flow grade ≤2 after the procedure in the absence of mechanical obstruction, dissection, or severe spasm.
Measured: Immediately after the index emergency PCI procedure
Secondary outcomes (9)
Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
Composite endpoint of all-cause death, non-fatal myocardial infarction, stroke, and any revascularization within 1-year after index emergency PCI.
Measured: 1 year after index emergency PCI procedure
Incidence of Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
The overall incidence of Patient-oriented Composite Endpoint (PoCE) within 1-year after index emergency PCI. PoCE is defined as a composite of all-cause death, non-fatal myocardial infarction, stroke, and any revascularization. This endpoint is assessed through in-hospital medical records, outpatient follow-up records, and telephone follow-up data.
Measured: 1 year after index emergency PCI procedure
Individual components of PoCE at 1-year follow-up
Incidence of each separate component event of PoCE: all-cause death, non-fatal myocardial infarction, stroke, any revascularization. This endpoint is assessed through in-hospital medical records, outpatient follow-up records, and telephone follow-up data.
Measured: 1 year after index emergency PCI procedure
Device-oriented Composite Endpoint (DoCE) at 1-year follow-up
Composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-driven target-lesion revascularization (CI-TLR) within 1-year after index emergency PCI.
Measured: 1 year after index emergency PCI procedure
Individual components of DoCE at 1-year follow-up
Incidence of each separate component event of DoCE: cardiac death, target-vessel myocardial infarction (TV-MI), clinically-driven target-lesion revascularization (CI-TLR).
Measured: 1 year after index emergency PCI procedure
Target Vessel Failure (TVF) at 1-year follow-up
Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target-vessel revascularization within 1-year after index emergency PCI.
Measured: 1 year after index emergency PCI procedure
Clinically-driven target-vessel revascularization at 1-year follow-up
Revascularization of target vessel triggered by clinical symptoms or myocardial ischemia evidence within 1-year after index emergency PCI.
Measured: 1 year after index emergency PCI procedure
Net Adverse Clinical Events (NACE) at 1-year follow-up
Composite of PoCE plus BARC-defined type 3 or 5 bleeding events within 1-year after index emergency PCI.
Measured: 1 year after index emergency PCI procedure
BARC type 3 or 5 bleeding events at 1-year follow-up
Bleeding events meeting BARC (Bleeding Academic Research Consortium) type 3 or type 5 criteria within 1-year after index emergency PCI.
Measured: 1 year after index emergency PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Jan 2019
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial Infarction (STEMI)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 668 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan He, MD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806370
- Sponsor's protocol ID
- KY20262334-C-1
- Acronym
- STEMI-DCB
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level patient data will not be shared due to patient privacy protection requirements and local hospital data management regulations. This is a single-center retrospective study based on historical medical records. No formal data sharing mechanism has been established. Aggregated study results may be published in peer-reviewed journals.
Publications
Cenko E, Badimon L, Vadala G, Merkus D, Antoniades C, Collet C, De Maria GL, Djordjevic-Dikic A, Drenjancevic I, Escaned J, Ferreiro JL, Fleming I, Guzik T, Manfrini O, Milicic D, Padro T, Porto I, Riou LM, Ryan N, Tousoulis D, van Beusekom HMM, Vavlukis M, Vilahur G, Zdravkovic M, Duncker DJ, Galassi AR, Bugiardini R; ESC EAPCI Document Reviewers: Gianluca Campo (Italy), and Felix Mahfoud (Switzerland). Pathophysiology, prevention, and management of coronary microvascular obstruction. Eur Heart J. 2026 Aug 14;47(31):4215-4241. doi: 10.1093/eurheartj/ehag334.
PubMed 42185090Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.
PubMed 31126887
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Drug-Coated Balloon Versus Drug-Eluting Stent In STEMI Patients With High Thrombus Burden: A Single-Center Retrospective Study Using Propensity Score Matching
- ClinicalTrials.gov ID
- NCT07806370
- Acronym / sponsor ID
- STEMI-DCB / KY20262334-C-1
- Keywords
- High thrombus burden, Drug-coated balloon, Drug-eluting stent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 668 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 8 Sep 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.
This is a single-center, retrospective, propensity-score-matched observational study. It aims to compare the rate of immediate slow-flow or no-reflow after percutaneous coronary intervention (PCI) between drug-coated balloon (DCB) and drug-eluting stent (DES) in STEMI patients with high thrombus burden. Medical records of eligible patients admitted between January 1, 2019 and June 30, 2025 will be reviewed. Propensity-score matching will be used to balance baseline characteristics of the two groups. Both procedural-related outcomes and 1-year clinical follow-up events will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-Coated Balloon (DCB) Cohort | – | Device: Drug-Coated Balloon (DCB)STEMI patients with high thrombus burden who received drug-coated balloon (DCB) as the final revascularization strategy for culprit coronary vessel |
| Drug-Eluting Stent (DES) Cohort | – | Device: Drug-Eluting Stent (DES)STEMI patients with high thrombus burden who received drug-eluting stent (DES) implantation as the final revascularization strategy for culprit coronary vessel, including bailout DES implantation after DCB. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single-center retrospective observational study. The study population consists of patients diagnosed with ST-elevation myocardial infarction (STEMI) with high thrombus burden (angiographic thrombus grade G2-G4) who underwent emergency percutaneous coronary intervention (PCI) at Xijing Hospital between January 1, 2019 and June 30, 2025. Eligible patients received either drug-coated balloon (DCB) or drug-eluting stent (DES) as the final revascularization strategy for the culprit vessel. Patients are identified from in-hospital medical records and coronary angiographic databases.
Key inclusion criteria (7 listed)
- Patients diagnosed with ST-elevation myocardial infarction (STEMI) undergoing emergency percutaneous coronary intervention (PCI) at this center:
- Angiographic thrombus grade of the culprit vessel is G2-G4.
- Reference vessel diameter of the culprit vessel: 2.25-4.0 mm.
- Complete pre-procedural and post-procedural coronary angiographic imaging data are available.
- Age ≥ 18 years old.
Key exclusion criteria (8 listed)
- Participation in other clinical trials.
- Cardiogenic shock or post-cardiac-arrest resuscitation state.
- Multi-vessel coronary artery disease.
- Severe calcified lesions requiring rotational atherectomy or shock-wave therapy.
- Only compliant or non-compliant plain balloon dilation performed.
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)A drug-coated balloon catheter used for percutaneous coronary intervention in patients with STEMI and high thrombus burden. The balloon surface is coated with an antiproliferative drug (e.g., paclitaxel) that is transferred to the vessel wall during balloon inflation, inhibiting neointimal hyperplasia. No permanent metal scaffold is implanted after DCB-only revascularization. | Device | Drug-Coated Balloon (DCB) Cohort |
| Drug-Eluting Stent (DES)A permanent coronary metal scaffold coated with an antiproliferative drug (e.g., sirolimus, everolimus, zotarolimus, or biolimus) implanted during percutaneous coronary intervention. The stent maintains vessel patency and the eluted drug inhibits neointimal hyperplasia. Used for culprit-vessel revascularization in STEMI patients with high thrombus burden, including bailout DES implantation after DCB predilation. | Device | Drug-Eluting Stent (DES) Cohort |
Primary outcome
Incidence of immediate slow-flow or no-reflow after PCI
Time frame: Immediately after the index emergency PCI procedure
The incidence of immediate slow-flow or no-reflow phenomenon after percutaneous coronary intervention (PCI) with either drug-coated balloon (DCB) or drug-eluting stent (DES). Slow-flow/no-reflow is defined as TIMI flow grade ≤2 after the procedure in the absence of mechanical obstruction, dissection, or severe spasm.
9 secondary outcomes
Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
Time frame: 1 year after index emergency PCI procedure
Incidence of Patient-oriented Composite Endpoint (PoCE) at 1-year follow-up
Time frame: 1 year after index emergency PCI procedure
Individual components of PoCE at 1-year follow-up
Time frame: 1 year after index emergency PCI procedure
Device-oriented Composite Endpoint (DoCE) at 1-year follow-up
Time frame: 1 year after index emergency PCI procedure
Individual components of DoCE at 1-year follow-up
Time frame: 1 year after index emergency PCI procedure
Target Vessel Failure (TVF) at 1-year follow-up
Time frame: 1 year after index emergency PCI procedure
Clinically-driven target-vessel revascularization at 1-year follow-up
Time frame: 1 year after index emergency PCI procedure
Net Adverse Clinical Events (NACE) at 1-year follow-up
Time frame: 1 year after index emergency PCI procedure
BARC type 3 or 5 bleeding events at 1-year follow-up
Time frame: 1 year after index emergency PCI procedure
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 8 Sep 2026.
- Results publication: PubMed 42185090Cenko E, Badimon L, Vadala G, Merkus D, Antoniades C, Collet C, De Maria GL, Djordjevic-Dikic A, Drenjancevic I, Escaned J, Ferreiro JL, Fleming I, Guzik T, Manfrini O, Milicic D, Padro T, Porto I, Riou LM, Ryan N, Tousoulis D, van Beusekom HMM, Vavlukis M, Vilahur G, Zdravkovic M, Duncker DJ, Galassi AR, Bugiardini R; ESC EAPCI Document Reviewers: Gianluca Campo (Italy), and Felix Mahfoud (Switzerland). Pathophysiology, prevention, and management of coronary microvascular obstruction. Eur Heart J. 2026 Aug 14;47(31):4215-4241. doi: 10.1093/eurheartj/ehag334.
- Results publication: PubMed 31126887Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.
- Individual participant dataSharing planned: No. Individual-level patient data will not be shared due to patient privacy protection requirements and local hospital data management regulations. This is a single-center retrospective study based on historical medical records. No formal data sharing mechanism has been established. Aggregated study results may be published in peer-reviewed journals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction (STEMI) and Acute Coronary Syndromes (ACS), run by Xijing Hospital 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 8 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 8 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 Yuan He, MD, PhD (+86-13991854483, heyuan820927@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of immediate slow-flow or no-reflow after PCI (time frame: Immediately after the index emergency PCI procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07806370, which also lists 2 linked publications.
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 8 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.