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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction; Computed Tomography; Optical Coherence Tomography (OCT); Percutaneous Coronary Intervention (PCI); Coronary Computed Tomographic Angiography; Medical Treatment
• Intervention / Treatment: Device: PCI with size matched DCB; Drug: GP IIbIIIa inhibitor or heparin & dual antiplatelet therapy

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. Elvin Kedhi, MD PhD; Phone Number: +1 514-934-1934; Email: ekedhi@me.com

Study Locations

• Poland
  • Lubin, Poland
    • Miedziowe Centrum Zdrowia SA
    • Contact: Dr. hab. n. med. Adrian Wlodarczak; Phone Number: +48 76 846 03 00; Email: wlodarczakadrian@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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;

2. OCT criteria (all 4 should be present):

   1. Presence of thrombus
   2. Absence of an overt ruptured plaque flap
   3. Area of stenosis of ≥ 50%
   4. Presence of atherosclerotic, predominantly lipidic or fibrotic plaque underneath (absence of major calcifications or calcified noduli)

Exclusion Criteria:

1. Culprit lesion located or extending in the Left Main coronary artery;
2. Presence of large coronary aneurysms;
3. Large thrombus burden (extending for more than > 15 mm);
4. Patients with severe tortuous lesions (OCT judged not possible);
5. Spontaneous coronary dissection is suspected;
6. Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5);
7. Life expectancy less than 2 years;
8. Pregnant or lactating women;
9. Patients currently participating in another trial;

10. Patients that are unable or unwilling to provide consent;

    OCT exclusion criteria:

11. Overt plaque rupture;
12. Thrombosed protruding calcified noduli;
13. Predominantly calcific lesions with calcium arc > 180° in the target segment;
14. Presence of calcium plaque of > 0.4 mm thick;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCI with size matched DCB; PCI with size matched drug-coated balloon	Device: PCI with size matched DCB; Subjects will be treated with PCI with size matched DCB (SeQuent)
Placebo Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure	Day 2-3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronary Computed Tomography Angiography (CCTA) assessed MLA at 1-year		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)	1 Year
TLF at 2-years	TLF is defined as Cardiac death, TV-MI, and CD-TLR	2 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CCTA-assessed plaque burden at baseline		Baseline
CCTA-assessed plaque burden post PCI		1 Week
CCTA-assessed plaque burden at 1-year		1 Year
CCTA-assessed lipid pool volume at baseline		Baseline
CCTA-assessed lipid pool volume post PCI		1 Week
CCTA-assessed lipid pool volume at 1-year		1 Year
Computed Tomography Fractionated Flow Reserve (CT-FFR) at baseline		Baseline
CT-FFR at 1-year		1 Year
Shear stress at lesion level at baseline measured by Elucid software		Baseline
Shear stress at lesion level at 1-year measured by Elucid software		1 Year
OCT-assessed thrombus volume at baseline		Baseline
OCT-assessed thrombus volume at control procedure		Day 2-3
OCT-assessed area of stenosis post index procedure		Periprocedural
OCT-assessed area of stenosis post control procedure		Day 2-3
OCT-assessed lumen gain	Difference between control and index MLA	Periprocedural and Day 2-3
OCT-assessed lipid arc at control procedure		Day 2-3

Collaborators and Investigators

• Sponsor: 3W-Research Collaboration Group

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: August 13, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: drug-coated balloon; CT-FFR; Plaque erosion; Minimum Lumen Area
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Carbohydrates; Glycosaminoglycans; Polysaccharides; Heparin; Percutaneous Coronary Intervention
• Other Study ID Numbers: 3W-RCG-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No