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A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation (ELICOPTER)

This study has been terminated.
(the study was halted after an interim analysis perfomed for a perceived excess of target vessel revascularization in the DEB+BMS arm)
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01637896
First received: July 7, 2012
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis


Condition Intervention Phase
Myocardial Ischemia
Device: DEB+BMS
Device: POBA+DES
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial

Further study details as provided by Ospedale San Donato:

Primary Outcome Measures:
  • angiographic binary re-restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    incidence of angiographic binary re-restenosis


Secondary Outcome Measures:
  • Late luminal loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    incidence of late luminal loss assessed by angiography

  • major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    incidence of major adverse cardiac events


Enrollment: 125
Study Start Date: June 2010
Study Completion Date: July 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DEB+BMS
drug-eluting balloon predilation and bare metal stent implantation
Device: DEB+BMS
drug-eluting balloon predilation and bare metal stent implantation
Active Comparator: POBA+DES
conventional balloon predilation and drug-eluting stent implantation
Device: POBA+DES
conventional balloon predilation and drug-eluting stent implantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age> 18 years
  • angina or stress test positive for ischemia
  • de novo coronary stenosis>50%

Exclusion Criteria:

  • recent myocardial infarction (<72h)
  • severe chronic kidney disease
  • allergy to Paclitaxel
  • contraindication for combined antiplatelet treatment
  • life expectancy <1 year
  • hypersensitivity or contraindication to one of the study drugs
  • lack of consent
  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: NCT01637896

Locations
Italy
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100
Sponsors and Collaborators
Leonardo Bolognese, MD
Investigators
Principal Investigator: Leonardo Bolognese, MD San Donato Hospital
  More Information

No publications provided

Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01637896     History of Changes
Other Study ID Numbers: Arezzo000
Study First Received: July 7, 2012
Last Updated: July 11, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014