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Balloon Elution and Late Loss Optimization (BELLO) Study (BELLO)

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)

Taxus (Paclitaxel eluting stent)

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring paclitaxel PTCA drug-eluting balloon, provisional spot stenting, coronary artery disease, Late Lumen Loss, Minimal lumen diameter, coronary artery disease in a small vessel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Irccs Fondazione Centro S.Raffaele Del Monte Tabor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)

Control Arm PES

Arm Description

IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare metal stenting (Bare Metal Stent).

Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion.

Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization

MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure

Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure

Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure

Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year

Binary Restenosis rate at 6 months follow-up

Full Information

NCT ID

NCT01086579

First Posted

March 11, 2010

Last Updated

August 13, 2013

Sponsor

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

1. Study Identification

Unique Protocol Identification Number

NCT01086579

Brief Title

Balloon Elution and Late Loss Optimization (BELLO) Study

Acronym

BELLO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Unknown status

Study Start Date

March 2010 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)

Arm Type

Experimental

Arm Description

IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare metal stenting (Bare Metal Stent).

Arm Title

Control Arm PES

Arm Type

Active Comparator

Arm Description

Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.

Intervention Type

Device

Intervention Name(s)

IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)

Other Intervention Name(s)

IN.PACT Falcon paclitaxel eluting balloon

Intervention Description

Coronary Artery Bypass Graft (CABG)

Intervention Type

Device

Intervention Name(s)

Taxus (Paclitaxel eluting stent)

Intervention Description

Percutaneous transluminal coronary angioplasty (PTCA) with stent

Primary Outcome Measure Information:

Title

Time Frame

6 Month

Secondary Outcome Measure Information:

Title

Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion.

Time Frame

day 1

Title

Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization

Time Frame

day 1

Title

MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure

Time Frame

30 days, 6 months,1, 2, 3 years

Title

Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure

Time Frame

6 months,1, 2, 3 years

Title

Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure

Time Frame

6 months,1, 2, 3 years

Title

Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year

Time Frame

1 Year

Title

Binary Restenosis rate at 6 months follow-up

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: