Investigation to Assess the Effects of Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes

NCT07783880 | Not Yet Recruiting DMC

• 1 other identifier: 3W-RCG-2
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

Plaque erosion; drug-coated balloon; CT-FFR; Minimum Lumen Area

Outcome Measures

Primary Outcomes (1)

• Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure

  Day 2-3

Secondary Outcomes (3)

• Coronary Computed Tomography Angiography (CCTA) assessed MLA at 1-year

  1 Year

• Target Lesion Failure (TLF) at 1-year

  1 Year

• TLF at 2-years

  2 Years

Other Outcomes (16)

• CCTA-assessed plaque burden at baseline

  Baseline

• CCTA-assessed plaque burden post PCI

  1 Week

• CCTA-assessed plaque burden at 1-year

  1 Year

Study Arms (2)

PCI with size matched DCB

ACTIVE COMPARATOR

PCI with size matched drug-coated balloon

Device: PCI with size matched DCB

GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy

PLACEBO COMPARATOR

Drug: GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy

Interventions

PCI with size matched DCB DEVICE

Subjects will be treated with PCI with size matched DCB (SeQuent)

PCI with size matched DCB

GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy DRUG

GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy

GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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);
• 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;
• 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;

Sponsors & Collaborators

• 3W-Research Collaboration Group: lead

Study Sites (1)

Miedziowe Centrum Zdrowia SA

Lubin, Poland

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Percutaneous Coronary Intervention; Heparin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Prof. Elvin Kedhi, MD PhD

CONTACT

+1 514-934-1934; ekedhi@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

PL (1)