NCT01086579

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-03-01
• Completion: 2014-05-01
• First posted: 2010-03-15
• Last updated: 2013-08-14

Locations

1 site across 1 country: Italy