Balloon Elution and Late Loss Optimization (BELLO) Study

Summary

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.

Conditions

• Coronary Artery Disease

Interventions

DEVICE

IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)

Coronary Artery Bypass Graft (CABG)

DEVICE

Taxus (Paclitaxel eluting stent)

Percutaneous transluminal coronary angioplasty (PTCA) with stent

Sponsors & Collaborators

• Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

  lead OTHER

Principal Investigators

• Antonio Colombo, Dr. · IRCCS Fondazione Centro S.Raffaele del Monte Tabor

• Corrado Tamburino, Prof. · Presidio Ospedaliero Ferrarotto di Catania

• Patrizia Presbitero, Prof · Istituto Clinico Humanitas di Rozzano (MI)

• Alberta Pangrazi, Dr. · Azienda Ospedaliera Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi di Ancona

• Roberto Violini, Dr. · Azienda Ospedaliera San Camillo Forlanini di Roma

• Francesca Buffoli, Dr. · Ospedale "C.Poma" di Mantova

• Maurizio Tespili, Dr. · Azienda Ospedaliera "Bolognini" di Seriate

• Fausto Castriota, Dr. · Citta' di Lecce Hospital di Lecce

• Alberto Cremonesi, Dr. · Villa Maria Cecilia Hospital di Cotignola

• Antonio Micari, Dr. · Villa Maria Eleonora Hospital di Palermo

• Alfredo Marchese, Dr. · Casa di Cura "AntheaHospital" di Bari

• Fabrizio Tomai, Dr. · European Hospital di Roma

• Massimo Margheri, Dr. · Ospedale S.Maria delle Croci AUSL di Ravenna

• Alberto Menozzi, Dr. · Azienda Ospedaliero-Universitaria di Parma

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2012-03-31

Completion

2014-05-31

Countries

• Italy

Study Locations