Balloon Elution and Late Loss Optimization (BELLO) Study

NCT01086579 | Unknown DMC

• 1 other identifier: BELLO
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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. 1.Treatment Arm: IN.PACT Falcon™ paclitaxel drug-eluting balloon (DEB) dilatation and provisional spot bare-metal stenting (BMS).
2. 2.Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.
3. 3.The means of LLL in the 2 groups are precisely equal
4. 4.A standard deviation in LLL of 0.5mm in both groups as demonstrated in the ISAR-SMART 3 and PEPCAD II trials
5. 5.A non-inferiority margin of 0.25mm between groups is clinically unimportant
6. 6.Null hypothesis (N0): mean LLL in DEB group is ≥0.25mm than that in the PES group (i.e. PES is superior to DEB)
7. 7.Alternative hypothesis 1 (H1): mean LLL between DEB and PES is \<0.25mm (i.e. DEB is non-inferior to PES)
8. 8.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.

Conditions

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

Outcome Measures

Primary Outcomes (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

  6 Month

Secondary Outcomes (7)

• 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

Study Arms (2)

Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)

EXPERIMENTAL

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)

Control Arm PES

ACTIVE COMPARATOR

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

Device: Taxus (Paclitaxel eluting stent)

Interventions

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

Coronary Artery Bypass Graft (CABG)

Also known as: IN.PACT Falcon paclitaxel eluting balloon

Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)

Taxus (Paclitaxel eluting stent) DEVICE

Percutaneous transluminal coronary angioplasty (PTCA) with stent

Control Arm PES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• \>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.

Sponsors & Collaborators

• Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS: lead

Study Sites (1)

Irccs Fondazione Centro S.Raffaele Del Monte Tabor

Milan, MI, 20100, Italy

Location

Related Publications (1)

• 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.

  PMID: 23158530 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Antonio Colombo, Dr.

  IRCCS Fondazione Centro S.Raffaele del Monte Tabor

  PRINCIPAL INVESTIGATOR

• Corrado Tamburino, Prof.

  Presidio Ospedaliero Ferrarotto di Catania

  PRINCIPAL INVESTIGATOR

• Patrizia Presbitero, Prof

  Istituto Clinico Humanitas di Rozzano (MI)

  PRINCIPAL INVESTIGATOR

• Alberta Pangrazi, Dr.

  Azienda Ospedaliera Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi di Ancona

  PRINCIPAL INVESTIGATOR

• Roberto Violini, Dr.

  Azienda Ospedaliera San Camillo Forlanini di Roma

  PRINCIPAL INVESTIGATOR

• Francesca Buffoli, Dr.

  Ospedale "C.Poma" di Mantova

  PRINCIPAL INVESTIGATOR

• Maurizio Tespili, Dr.

  Azienda Ospedaliera "Bolognini" di Seriate

  PRINCIPAL INVESTIGATOR

• Fausto Castriota, Dr.

  Citta' di Lecce Hospital di Lecce

  PRINCIPAL INVESTIGATOR

• Alberto Cremonesi, Dr.

  Villa Maria Cecilia Hospital di Cotignola

  PRINCIPAL INVESTIGATOR

• Antonio Micari, Dr.

  Villa Maria Eleonora Hospital di Palermo

  PRINCIPAL INVESTIGATOR

• Alfredo Marchese, Dr.

  Casa di Cura "AntheaHospital" di Bari

  PRINCIPAL INVESTIGATOR

• Fabrizio Tomai, Dr.

  European Hospital di Roma

  PRINCIPAL INVESTIGATOR

• Massimo Margheri, Dr.

  Ospedale S.Maria delle Croci AUSL di Ravenna

  PRINCIPAL INVESTIGATOR

• Alberto Menozzi, Dr.

  Azienda Ospedaliero-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2014
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

IT (1)