Balloon Elution and Late Loss Optimization (BELLO) Study
NCT ID: NCT01086579
Last Updated: 2013-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
182 participants
INTERVENTIONAL
2010-03-31
2014-05-31
Brief Summary
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1. Treatment Arm: IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare-metal stenting (BMS).
2. Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.
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:
1. The means of LLL in the 2 groups are precisely equal
2. A standard deviation in LLL of 0.5mm in both groups as demonstrated in the ISAR-SMART 3 and PEPCAD II trials
3. A non-inferiority margin of 0.25mm between groups is clinically unimportant
Based on these assumptions:
1. Null hypothesis (N0): mean LLL in DEB group is ≥0.25mm than that in the PES group (i.e. PES is superior to DEB)
2. Alternative hypothesis 1 (H1): mean LLL between DEB and PES is \<0.25mm (i.e. DEB is non-inferior to PES)
3. Alternative hypothesis 2 (H2): mean LLL between DEB and PES \<0 (i.e. DEB is superior to PES) Based on the above calculations, a sample size of 77 patients will be required in each group to show non-inferiority of DEB vs. PES with an α error of 0.025 (one-sided Z test) and a power of 80%. To account for a 20% rate of withdrawal, lost to follow-up or not presenting for follow-up angiography, a total of 182 patients (91 in each group) will be randomized.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)
IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare metal stenting (Bare Metal Stent).
IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
Coronary Artery Bypass Graft (CABG)
Control Arm PES
Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.
Taxus (Paclitaxel eluting stent)
Percutaneous transluminal coronary angioplasty (PTCA) with stent
Interventions
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IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
Coronary Artery Bypass Graft (CABG)
Taxus (Paclitaxel eluting stent)
Percutaneous transluminal coronary angioplasty (PTCA) with stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient providing written informed consent.
* Patients with stable angina pectoris (Canadian Cardiovascular Society \[CCS\] 1, 2 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia.
* Patients who are eligible for coronary revascularization (angioplasty and/or CABG).
* Female patients with child bearing potential must have a negative pregnancy test within one week before treatment and must use adequate contraception.
* Native coronary artery.
* De novo lesion.
* Reference vessel diameter \< 2.8mm by visual estimate.
* Target lesion with a visually estimated stenosis \>50%.
* Target lesion length \< 25mm by visual estimate.
* A maximum of 2 epicardial vessels requiring revascularization.
* A maximum of 2 target lesions can be included (In the case of treatment of more than one lesion, the treatment selected will remain the same).
Exclusion Criteria
* Patients enrolled in another study with any investigational drug or device within the past 30 days.
* Patients scheduled for a major surgical intervention within 6 months of enrolment in the study.
* Patients with acute (\< 24h) or recent (≤ 48 hours) myocardial infarction.
* Patients with a contraindication to an emergency coronary bypass surgery.
* Any individual who may refuse a blood transfusion.
* Patients with serum creatinine \>2.0mg/dL or \>180umol/L.
* Patients with severe congestive heart failure.
* Patients who had a cerebral stroke \<6 months prior to the Index Procedure.
* EF (Ejection Fraction) \< 30%.
* Patients with any known allergy, hypersensitivity or intolerance to acetylsalicylic acid (ASA), Clopidogrel or Ticlopidine, Paclitaxel.
* Any known allergy to contrast medium that cannot be pre-treated.
* \>2 epicardial vessels requiring revascularization.
* Target lesion distance from the ostium of left anterior descending coronary artery (LAD)/left circumflex coronary artery (LCX)/right coronary artery (RCA) is \< 5 mm.
* Target lesion is located in either a venous or arterial graft.
* Target vessel contains a previously implanted stent.
* Angiographic evidence of thrombus at the target site.
* Chronic total occlusions.
* Restenotic lesions.
* Bifurcation lesions which the operator decides a 2-stent technique as intention-to-treat is required OR bifurcations with side branches ≥ 2.5mm.
* Failure to successfully treat non-target lesions within the target vessel (non-target lesions must be treated prior the target lesion).
* Greater than 2 non-target lesions treated during the index procedure.
* Previous Percutaneous Coronary Intervention (PCI) within the last 3 months.
18 Years
ALL
No
Sponsors
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Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
OTHER
Responsible Party
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Principal Investigators
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Antonio Colombo, Dr.
Role: PRINCIPAL_INVESTIGATOR
IRCCS Fondazione Centro S.Raffaele del Monte Tabor
Corrado Tamburino, Prof.
Role: PRINCIPAL_INVESTIGATOR
Presidio Ospedaliero Ferrarotto di Catania
Patrizia Presbitero, Prof
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas di Rozzano (MI)
Alberta Pangrazi, Dr.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi di Ancona
Roberto Violini, Dr.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera San Camillo Forlanini di Roma
Francesca Buffoli, Dr.
Role: PRINCIPAL_INVESTIGATOR
Ospedale "C.Poma" di Mantova
Maurizio Tespili, Dr.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera "Bolognini" di Seriate
Fausto Castriota, Dr.
Role: PRINCIPAL_INVESTIGATOR
Citta' di Lecce Hospital di Lecce
Alberto Cremonesi, Dr.
Role: PRINCIPAL_INVESTIGATOR
Villa Maria Cecilia Hospital di Cotignola
Antonio Micari, Dr.
Role: PRINCIPAL_INVESTIGATOR
Villa Maria Eleonora Hospital di Palermo
Alfredo Marchese, Dr.
Role: PRINCIPAL_INVESTIGATOR
Casa di Cura "AntheaHospital" di Bari
Fabrizio Tomai, Dr.
Role: PRINCIPAL_INVESTIGATOR
European Hospital di Roma
Massimo Margheri, Dr.
Role: PRINCIPAL_INVESTIGATOR
Ospedale S.Maria delle Croci AUSL di Ravenna
Alberto Menozzi, Dr.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria di Parma
Locations
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Irccs Fondazione Centro S.Raffaele Del Monte Tabor
Milan, MI, Italy
Countries
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References
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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.
Other Identifiers
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BELLO
Identifier Type: -
Identifier Source: org_study_id