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Prospective multicentre randomized (1:1) investigator initiated study, in which consecutive patients undergoing percutaneous revascularization of small coronary vessels will be assigned to one of the two study arms:
Eligible subjects with coronary artery disease in a small vessel (reference diameter<2.8mm) will be consecutively screened and enrolled based on the inclusion and exclusion criteria
The objective of the study is to assess the non-inferiority of the DEB to the PES as regards to primary endpoint of mean late lumen loss (LLL) at 6 months, defined as the difference between postprocedural minimum luminal (MLD) diameter and follow-up MLD, as assessed by quantitative coronary angiography and is based on the following assumptions:
Based on these assumptions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm (IN.PACT Falcon Drug Eluting Balloon) | Experimental | IN.PACT Falconâ„¢ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare metal stenting (Bare Metal Stent). |
|
| Control Arm PES | Active Comparator | Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon) | Device | Coronary Artery Bypass Graft (CABG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss (LLL) at 6 months follow-up defined as the difference between postprocedural minimum luminal diameter and follow-up minimum luminal diameter, as assessed by quantitative coronary angiography | 6 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion. | day 1 | |
| Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization |
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Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
Angiographic exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Colombo, Dr. | IRCCS Fondazione Centro S.Raffaele del Monte Tabor | Principal Investigator |
| Corrado Tamburino, Prof. | Presidio Ospedaliero Ferrarotto di Catania | Principal Investigator |
| Patrizia Presbitero, Prof | Istituto Clinico Humanitas di Rozzano (MI) | Principal Investigator |
| Alberta Pangrazi, Dr. | Azienda Ospedaliera Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi di Ancona | Principal Investigator |
| Roberto Violini, Dr. | Azienda Ospedaliera San Camillo Forlanini di Roma | Principal Investigator |
| Francesca Buffoli, Dr. | Ospedale "C.Poma" di Mantova | Principal Investigator |
| Maurizio Tespili, Dr. | Azienda Ospedaliera "Bolognini" di Seriate | Principal Investigator |
| Fausto Castriota, Dr. | Citta' di Lecce Hospital di Lecce | Principal Investigator |
| Alberto Cremonesi, Dr. | Villa Maria Cecilia Hospital di Cotignola |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs Fondazione Centro S.Raffaele Del Monte Tabor | Milan | MI | 20100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23158530 | Derived | Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Taxus (Paclitaxel eluting stent) | Device | Percutaneous transluminal coronary angioplasty (PTCA) with stent |
|
| day 1 |
| MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure | 30 days, 6 months,1, 2, 3 years |
| Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure | 6 months,1, 2, 3 years |
| Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure | 6 months,1, 2, 3 years |
| Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year | 1 Year |
| Binary Restenosis rate at 6 months follow-up | 6 months |
| Principal Investigator |
| Antonio Micari, Dr. | Villa Maria Eleonora Hospital di Palermo | Principal Investigator |
| Alfredo Marchese, Dr. | Casa di Cura "AntheaHospital" di Bari | Principal Investigator |
| Fabrizio Tomai, Dr. | European Hospital di Roma | Principal Investigator |
| Massimo Margheri, Dr. | Ospedale S.Maria delle Croci AUSL di Ravenna | Principal Investigator |
| Alberto Menozzi, Dr. | Azienda Ospedaliero-Universitaria di Parma | Principal Investigator |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |