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Coronary Artery DiseaseBELLONCT01086579

Balloon Elution and Late Loss Optimization (BELLO) Study

A study testing IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon) and Taxus (Paclitaxel eluting stent) in people with Coronary Artery Disease, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon) and Taxus (Paclitaxel eluting stent)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
1 siteItaly
Study dates
Mar 2010to May 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Irccs Fondazione Centro S.Raffaele Del Monte Tabor

    Milan, MI, 20100

Other trials in Italy

About this study

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

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.
Read more

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.
Being tested
IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon), Taxus (Paclitaxel eluting stent)
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
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called IN.PACT Falcon paclitaxel eluting balloon

    Coronary Artery Bypass Graft (CABG)

  • Taxus (Paclitaxel eluting stent)Device

    Percutaneous transluminal coronary angioplasty (PTCA) with stent

Study groups in NCT01086579
Study groupRoleWhat they receive
Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)ExperimentalIN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare metal stenting (Bare Metal Stent).
Receives: Device: IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
Control Arm PESActive comparatorControl Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.
Receives: Device: Taxus (Paclitaxel eluting stent)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 Month

Secondary outcomes (7)

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

    Measured: day 1

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

    Measured: day 1

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

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

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

    Measured: 6 months,1, 2, 3 years

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

    Measured: 6 months,1, 2, 3 years

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

    Measured: 1 Year

  7. Binary Restenosis rate at 6 months follow-up

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2012
  4. Study completionMay 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01086579
Sponsor's protocol ID
BELLO
Acronym
BELLO
Status last verified
Aug 2013
First submitted
11 Mar 2010
Last updated
14 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14.

    PubMed 23158530

Questions about this trial

What is this clinical trial studying?

A study testing IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon) and Taxus (Paclitaxel eluting stent) in people with Coronary Artery Disease, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01086579, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.

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