Myocardial InfarctionDCB-PENCT07783880
Investigation to Assess the Effects of Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes
A study testing PCI with size matched DCB and GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy in people with Myocardial Infarction and Percutaneous Coronary Intervention (PCI), run by 3W-Research Collaboration Group at 1 site in Poland.
Trial summary
Drug eluting balloon angioplasty might be a better alternative than medical treatment or stenting in subjects with plaque erosion, which is the second most common cause of myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Percutaneous Coronary Intervention (PCI), Medical Treatment
- What is being tested?
- PCI with size matched DCB and GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2026to 1 Jan 2030
- 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
- Patients aged ≥18 years presenting with MI where the culprit de-novo (stent restenosis/thrombosis excluded) lesion has a Thrombolysis in Myocardial Infarction (TIMI) flow of ≥ I with signs of thrombus on angiographic (or CCTA followed by conventional coronary angiography) evaluation located in a native coronary artery (a by-pass graft vessel excluded) addressable by PCI;
- OCT criteria (all 4 should be present):
- Presence of thrombus
- Absence of an overt ruptured plaque flap
- Area of stenosis of ≥ 50%
- Presence of atherosclerotic, predominantly lipidic or fibrotic plaque underneath (absence of major calcifications or calcified noduli)
Who cannot join
- Culprit lesion located or extending in the Left Main coronary artery;
- Presence of large coronary aneurysms;
- Large thrombus burden (extending for more than > 15 mm);
- Patients with severe tortuous lesions (OCT judged not possible);
- Spontaneous coronary dissection is suspected;
- Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5);
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- Life expectancy less than 2 years;
- Pregnant or lactating women;
- Patients currently participating in another trial;
- Patients that are unable or unwilling to provide consent;
- OCT exclusion criteria:
- Overt plaque rupture;
- Thrombosed protruding calcified noduli;
- Predominantly calcific lesions with calcium arc > 180° in the target segment;
- Presence of calcium plaque of > 0.4 mm thick;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Miedziowe Centrum Zdrowia SA
Lubin
Dr. hab. n. med. Adrian Wlodarczak, +48 76 846 03 00, wlodarczakadrian@gmail.com
About this study
Official title: Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes
Drug eluting balloon angioplasty might be a better alternative than medical treatment or stenting in subjects with plaque erosion, which is the second most common cause of myocardial infarction.
The main objective of this pilot study is to gain clear insights on the effect of percutaneous coronary intervention (PCI) with size matched DCB (SeQuent) as compared to treatment with GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy in a predominantly Caucasian population at 2 days and at 1 year after the procedure.
- Conditions
- Myocardial Infarction, Percutaneous Coronary Intervention (PCI), Medical Treatment, Coronary Computed Tomographic Angiography, Computed Tomography, Optical Coherence Tomography (OCT)
- Being tested
- PCI with size matched DCB, GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy
- Keywords
- Plaque erosion, drug-coated balloon, CT-FFR, Minimum Lumen Area
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI with size matched DCBDevice
Subjects will be treated with PCI with size matched DCB (SeQuent)
GP IIbIIIa inhibitor or heparin & dual antiplatelet therapyDrug
GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy
| Study group | Role | What they receive |
|---|---|---|
| PCI with size matched DCB | Active comparator | PCI with size matched drug-coated balloon Receives: Device: PCI with size matched DCB |
| GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy | Placebo comparator | Not described Receives: Drug: GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure
Measured: Day 2-3
Secondary outcomes (3)
Coronary Computed Tomography Angiography (CCTA) assessed MLA at 1-year
Measured: 1 Year
Target Lesion Failure (TLF) at 1-year
TLF is defined as Cardiac death, Target Vessel-MI (TV-MI), and Clinically-Driven Target Lesion Revascularization (CD-TLR)
Measured: 1 Year
TLF at 2-years
TLF is defined as Cardiac death, TV-MI, and CD-TLR
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 3W-Research Collaboration Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783880
- Sponsor's protocol ID
- 3W-RCG-2
- Acronym
- DCB-PE
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT07783880
- Acronym / sponsor ID
- DCB-PE / 3W-RCG-2
- Conditions
- Myocardial Infarction, Percutaneous Coronary Intervention (PCI), Medical Treatment, Coronary Computed Tomographic Angiography, Computed Tomography, Optical Coherence Tomography (OCT)
- Keywords
- Plaque erosion, drug-coated balloon, CT-FFR, Minimum Lumen Area
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- 3W-Research Collaboration GroupUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 25 Aug 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.
Drug eluting balloon angioplasty might be a better alternative than medical treatment or stenting in subjects with plaque erosion, which is the second most common cause of myocardial infarction.
The main objective of this pilot study is to gain clear insights on the effect of percutaneous coronary intervention (PCI) with size matched DCB (SeQuent) as compared to treatment with GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy in a predominantly Caucasian population at 2 days and at 1 year after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI with size matched DCB | Active comparator | Device: PCI with size matched DCBPCI with size matched drug-coated balloon |
| GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy | Placebo comparator | Drug: GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged ≥18 years presenting with MI where the culprit de-novo (stent restenosis/thrombosis excluded) lesion has a Thrombolysis in Myocardial Infarction (TIMI) flow of ≥ I with signs of thrombus on angiographic (or CCTA followed by conventional coronary angiography) evaluation located in a native coronary artery (a by-pass graft vessel excluded) addressable by PCI;
- OCT criteria (all 4 should be present):
Key exclusion criteria (15 listed)
- Culprit lesion located or extending in the Left Main coronary artery;
- Presence of large coronary aneurysms;
- Large thrombus burden (extending for more than > 15 mm);
- Patients with severe tortuous lesions (OCT judged not possible);
- Spontaneous coronary dissection is suspected;
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 |
|---|---|---|
| PCI with size matched DCBSubjects will be treated with PCI with size matched DCB (SeQuent) | Device | PCI with size matched DCB |
| GP IIbIIIa inhibitor or heparin & dual antiplatelet therapyGP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy | Drug | GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy |
Primary outcome
Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure
Time frame: Day 2-3
3 secondary outcomes
Coronary Computed Tomography Angiography (CCTA) assessed MLA at 1-year
Time frame: 1 Year
Target Lesion Failure (TLF) at 1-year
Time frame: 1 Year
TLF at 2-years
Time frame: 2 Years
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 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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?
A study testing PCI with size matched DCB and GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy in people with Myocardial Infarction and Percutaneous Coronary Intervention (PCI), run by 3W-Research Collaboration Group at 1 site in Poland.
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 15 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: opening soon, as of the sponsor's last update on 25 Aug 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 Poland. 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. Some participants in this study may receive a placebo. 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 Prof. Elvin Kedhi, MD PhD (+1 514-934-1934, ekedhi@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure (time frame: Day 2-3). 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 25 Aug 2026.