NCT07783880Not yet recruiting
Investigation to Assess the Effects of Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes
Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 13 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2029
- Lead sponsor
- 3W-Research Collaboration Group
- Diseases
- Coronary artery disease
- NCT number
- NCT07783880
What you commit to
- Study type: Interventional
- Planned participants: 62
- From 1 Oct 2026 to the primary completion date, 1 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Renal insufficiency (Glomerular Filtration Rate (GFR) \< 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5);
- Predominantly calcific lesions with calcium arc \> 180° in the target segment;
- Presence of calcium plaque of \> 0.4 mm thick;
Other
- 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;
- 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;
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Miedziowe Centrum Zdrowia SA Coordinator of this site? Confirm its status | Lubin | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.