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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Coronary Artery Bypass Graft (CABG)
Percutaneous transluminal coronary angioplasty (PTCA) with stent
Irccs Fondazione Centro S.Raffaele Del Monte Tabor
Milan, MI, Italy
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
Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion.
Time frame: day 1
Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization
Time frame: day 1
MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure
Time frame: 30 days, 6 months,1, 2, 3 years
Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure
Time frame: 6 months,1, 2, 3 years
Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure
Time frame: 6 months,1, 2, 3 years
Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year
Time frame: 1 Year
Binary Restenosis rate at 6 months follow-up
Time frame: 6 months
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