Balloon Elution and Late Loss Optimization (BELLO) Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
* Device: Taxus (Paclitaxel eluting stent)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)<br>IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare metal stenting (Bare Metal Stent). | Device: IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)<br>* Coronary Artery Bypass Graft (CABG)<br>* Other names: IN.PACT Falcon paclitaxel eluting balloon;|
| Active Comparator: Control Arm PES<br>Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice. | Device: Taxus (Paclitaxel eluting stent)<br>* Percutaneous transluminal coronary angioplasty (PTCA) with stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paclitaxel PTCA drug-eluting balloon, provisional spot stenting, coronary artery disease, Late Lumen Loss, Minimal lumen diameter, coronary artery disease in a small vessel