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This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Study population will consist of 240 patients with stable or unstable angina
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new generation DEB | Other | drug-eluting balloon (DEB) |
|
| second generation DES | Other | standard therapy with second generation drug-eluting stent (DES) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-eluting balloon | Device | Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Verify the non-inferiority of DCB | the primary objective of the study is the non-inferiority of the DCB compared to DES in terms of absence of restenosis, defined as reoccurrence of stenoses of at least 50% of the lumen of the vessel at angiographic follow-up (6 months after surgery). | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with changes of vessels lumen | any differences between groups in terms of vascular changes to angiography. | up to 12 months |
| Concentration in blood chemistry | changes of concentration in blood chemistry between the groups |
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Inclusion Criteria
Exclusion criteria
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39718036 | Derived | Fezzi S, Trevisanello A, Buccheri D, Borgi M, Orrego PS, Zoccai GB, Cortese B. Physiological Performance of Drug-Coated Balloons in Small Coronary Arteries PICCOLETO II muFR. Catheter Cardiovasc Interv. 2025 Feb;105(3):643-649. doi: 10.1002/ccd.31376. Epub 2024 Dec 24. | |
| 37164603 | Derived | Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F. Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC Cardiovasc Interv. 2023 May 8;16(9):1054-1061. doi: 10.1016/j.jcin.2023.02.011. Epub 2023 Apr 19. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| drug-eluting stent | Device | Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). |
|
| up to 6 months |
| Number of Participants with adverse events | appearance of major cardiovascular adverse events | up to 12 months |
| 33248978 | Derived | Cortese B, Di Palma G, Guimaraes MG, Piraino D, Orrego PS, Buccheri D, Rivero F, Perotto A, Zambelli G, Alfonso F. Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2840-2849. doi: 10.1016/j.jcin.2020.08.035. Epub 2020 Nov 25. |