Computed Tomography, Coronary Computed Tomographic Angiography, Medical Treatment, Myocardial Infarction, Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
Plaque erosion, drug-coated balloon, CT-FFR, Minimum Lumen Area
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.
Interventions
DEVICEPCI with size matched DCB
Subjects will be treated with PCI with size matched DCB (SeQuent)
DRUGGP IIbIIIa inhibitor or heparin & dual antiplatelet therapy
GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy
Sponsors
3W-Research Collaboration Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optical Coherence Tomography (OCT)-assessed Minimum Lumen Area (MLA) during the control procedure | Day 2-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coronary Computed Tomography Angiography (CCTA) assessed MLA at 1-year | 1 Year | — |
| Target Lesion Failure (TLF) at 1-year | 1 Year | TLF is defined as Cardiac death, Target Vessel-MI (TV-MI), and Clinically-Driven Target Lesion Revascularization (CD-TLR) |
| TLF at 2-years | 2 Years | TLF is defined as Cardiac death, TV-MI, and CD-TLR |
Countries
Poland
Contacts
CONTACTProf. Elvin Kedhi, MD PhD
Outcome results
None listed