Back to resultsA Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation (ELICOPTER)
Primary Purpose
Myocardial Ischemia
Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
DEB+BMS
POBA+DES
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia
Eligibility 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
Sites / Locations
- Cardiovascular Department, Ospedale S.Donato
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DEB+BMS
POBA+DES
Arm Description
drug-eluting balloon predilation and bare metal stent implantation
conventional balloon predilation and drug-eluting stent implantation
Outcomes
Primary Outcome Measures
angiographic binary re-restenosis
incidence of angiographic binary re-restenosis
Secondary Outcome Measures
Late luminal loss
incidence of late luminal loss assessed by angiography
major adverse cardiac events
incidence of major adverse cardiac events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01637896
Brief Title
A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation
Acronym
ELICOPTER
Official Title
A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
the study was halted after an interim analysis perfomed for a perceived excess of target vessel revascularization in the DEB+BMS arm
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leonardo Bolognese, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DEB+BMS
Arm Type
Experimental
Arm Description
drug-eluting balloon predilation and bare metal stent implantation
Arm Title
POBA+DES
Arm Type
Active Comparator
Arm Description
conventional balloon predilation and drug-eluting stent implantation
Intervention Type
Device
Intervention Name(s)
DEB+BMS
Intervention Description
drug-eluting balloon predilation and bare metal stent implantation
Intervention Type
Device
Intervention Name(s)
POBA+DES
Intervention Description
conventional balloon predilation and drug-eluting stent implantation
Primary Outcome Measure Information:
Title
angiographic binary re-restenosis
Description
incidence of angiographic binary re-restenosis
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Late luminal loss
Description
incidence of late luminal loss assessed by angiography
Time Frame
9 months
Title
major adverse cardiac events
Description
incidence of major adverse cardiac events
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Bolognese, MD
Organizational Affiliation
San Donato Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Department, Ospedale S.Donato
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation
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