Balloon Elution and Late Loss Optimization (BELLO) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
ClinicalTrials.gov Identifier:
NCT01086579
First received: March 11, 2010
Last updated: August 13, 2013
Last verified: August 2013

March 11, 2010
August 13, 2013
March 2010
March 2012   (final data collection date for primary outcome measure)
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 [ Time Frame: 6 Month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01086579 on ClinicalTrials.gov Archive Site
  • Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion. [ Time Frame: day 1 ] [ Designated as safety issue: Yes ]
  • Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization [ Time Frame: day 1 ] [ Designated as safety issue: Yes ]
  • MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure [ Time Frame: 30 days, 6 months,1, 2, 3 years ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure [ Time Frame: 6 months,1, 2, 3 years ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure [ Time Frame: 6 months,1, 2, 3 years ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  • Binary Restenosis rate at 6 months follow-up [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Balloon Elution and Late Loss Optimization (BELLO) Study
Balloon Elution and Late Loss Optimization (BELLO) Study: A Multicentre Randomized Study of the IN.PACT Falcon™ Paclitaxel Drug-eluting Balloon to Reduce Restenosis in Small Coronary Vessels

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:

  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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
    Coronary Artery Bypass Graft (CABG)
    Other Name: IN.PACT Falcon paclitaxel eluting balloon
  • Device: Taxus (Paclitaxel eluting stent)
    Percutaneous transluminal coronary angioplasty (PTCA) with stent
  • Experimental: 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).
    Intervention: Device: IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
  • Active Comparator: Control Arm PES
    Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.
    Intervention: Device: Taxus (Paclitaxel eluting stent)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
182
May 2014
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years.
  • 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.

Angiographic Inclusion Criteria:

  • 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 unable to give informed consent.
  • 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.

Angiographic exclusion criteria:

  • >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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01086579
BELLO
Yes
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
Not Provided
Principal Investigator: 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
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
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP