Balloon Elution and Late Loss Optimization (BELLO) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
ClinicalTrials.gov Identifier:
NCT01086579
First received: March 11, 2010
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.

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.

Condition Intervention
Coronary Artery Disease
Device: IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)
Device: Taxus (Paclitaxel eluting stent)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus:

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 [ Time Frame: 6 Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Device Success: ability of the Investigational Device to be delivered, dilate, and be retrieved from the target lesion. [ Time Frame: day 1 ] [ Designated as safety issue: Yes ]
  • Procedural Success: defined as Device Success without the occurrence of Major Adverse Cardiac Events (MACE) during the index hospitalization [ Time Frame: day 1 ] [ Designated as safety issue: Yes ]
  • MACE rate through 30 days, 6 months,1, 2, 3 years post index procedure [ Time Frame: 30 days, 6 months,1, 2, 3 years ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization (TLR) at 6 months,1, 2, 3 years post index procedure [ Time Frame: 6 months,1, 2, 3 years ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) at 6 months,1, 2, 3 years post index procedure [ Time Frame: 6 months,1, 2, 3 years ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF), defined as cardiac death, Myocardial Infarction (MI) or TVR at 1 year [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  • Binary Restenosis rate at 6 months follow-up [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 182
Study Start Date: March 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm (IN.PACT Falcon Drug Eluting Balloon)
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)
Coronary Artery Bypass Graft (CABG)
Other Name: IN.PACT Falcon paclitaxel eluting balloon
Active Comparator: Control Arm PES
Control Arm: paclitaxel-eluting stent (PES) implantation as per standard practice.
Device: Taxus (Paclitaxel eluting stent)
Percutaneous transluminal coronary angioplasty (PTCA) with stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086579

Locations
Italy
Irccs Fondazione Centro S.Raffaele Del Monte Tabor
Milan, MI, Italy, 20100
Sponsors and Collaborators
Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
Investigators
Principal Investigator: 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
  More Information

Additional Information:
No publications provided by Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus
ClinicalTrials.gov Identifier: NCT01086579     History of Changes
Other Study ID Numbers: BELLO
Study First Received: March 11, 2010
Last Updated: August 13, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus:
paclitaxel PTCA drug-eluting balloon
provisional spot stenting
coronary artery disease
Late Lumen Loss
Minimal lumen diameter
coronary artery disease in a small vessel

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014