NCT01086579UnknownNot Applicable
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
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS2 sites in 1 country182 target enrollmentStarted: March 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 182
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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:
- Treatment Arm: IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare-metal stenting (BMS).
- 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:
- The means of LLL in the 2 groups are precisely equal
- A standard deviation in LLL of 0.5mm in both groups as demonstrated in the ISAR-SMART 3 and PEPCAD II trials
- A non-inferiority margin of 0.25mm between groups is clinically unimportant
Based on these assumptions:
- Null hypothesis (N0): mean LLL in DEB group is ≥0.25mm than that in the PES group (i.e. PES is superior to DEB)
- Alternative hypothesis 1 (H1): mean LLL between DEB and PES is <0.25mm (i.e. DEB is non-inferior to PES)
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion.(day 1)
- 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)
- Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure(6 months,1, 2, 3 years)
- 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)
Investigators
Study Sites (2)
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