Coronary Artery Disease
Conditions
Keywords
paclitaxel PTCA drug-eluting balloon, provisional spot stenting, coronary artery disease, Late Lumen Loss, Minimal lumen diameter, coronary artery disease in a small vessel
Brief 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.
Interventions
DEVICEIN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
Coronary Artery Bypass Graft (CABG)
DEVICETaxus (Paclitaxel eluting stent)
Percutaneous transluminal coronary angioplasty (PTCA) with stent
Sponsors
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 6 Month |
Secondary
| Measure | Time frame |
|---|---|
| Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization | day 1 |
| MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure | 30 days, 6 months,1, 2, 3 years |
| Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure | 6 months,1, 2, 3 years |
| Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion. | day 1 |
| Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year | 1 Year |
| Binary Restenosis rate at 6 months follow-up | 6 months |
| Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure | 6 months,1, 2, 3 years |
Countries
Italy
Outcome results
None listed