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

July 11, 2012 updated by: Leonardo Bolognese, MD

A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • Cardiovascular Department, Ospedale S.Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
angiographic binary re-restenosis
Time Frame: 9 months
incidence of angiographic binary re-restenosis
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late luminal loss
Time Frame: 9 months
incidence of late luminal loss assessed by angiography
9 months
major adverse cardiac events
Time Frame: 12 months
incidence of major adverse cardiac events
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leonardo Bolognese, MD

Investigators

  • Principal Investigator: Leonardo Bolognese, MD, San Donato Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 7, 2012

First Submitted That Met QC Criteria

July 7, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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