To Achieve an Early Reendothelialization at the Expense of Low Restenosis: The EREMUS Study (EREMUS)

July 21, 2010 updated by: Ospedale della Misericordia

Early Re-Endothelialization Might Not be the Unique Solution to Prevent Restenosis. The EREMUS Study

The investigators sought to discover which one of the following strategies is the safest for patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous stent; Genous stent; drug eluting stent (paclitaxel).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

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
      • Grosseto, Italy, 58100
        • U.O. Emodinamica, Ospedale della Misericordia

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable or unstable angina pectoris suitable to PCI of at least one coronary vessel
  • Age >18 years

Exclusion Criteria:

  • Recent (<72 hours) acute myocardial infarction
  • Creatinine clearance <40 ml/min
  • Allergy or hypersensitivity to at least two between: aspirin, clopidogrel, heparin, bivalirudin, paclitaxel, contrast media
  • Life expectancy <1 year

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: 1
Paclitaxel eluting balloon (Elutax) + Genous stent
Device: Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent
Predilatation with paclitaxel-eluting balloon, then stenting of the lesion with Genous stent
Other Names:
  • Elutax balloon, Aachen Resonance GmbH, Bavaria, Germany;
  • Genous stent, Orbus Neich, Fort Lauderdale, FL.
Experimental: 2
Uncoated balloon + Genous stent
Device: Percutaneous coronary intervention: Uncoated balloon + Genous stent
Predilatation with uncoated balloon, the stenting with Genous stent.
Other Names:
  • Genous stent, Orbus Neich, Fort Lauderdale, FL.
Active Comparator: 3
Drug eluting stent (Taxus stent)
Device: Percutaneous coronary intervention: Drug eluting stent (Taxus stent)
Predilatation with uncoated balloon, the placement of a Taxus stent.
Other Names:
  • Taxus stent, Boston Scientific, Natick, MA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late luminal loss between the three groups at 6 months angiographic follow up.
Time Frame: 6 months
6 months
Percent of stent struts covered by endothelium at optical coherence tomography, during 6 months angiographic follow up.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Angiographic restenosis (6 months angiographic follow up).
Time Frame: 6 months
6 months
Net adverse clinical events at 6 months (death, myocardial infarction, target lesion revascularization, bleedings as from Acuity scale).
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Ospedale della Misericordia

Investigators

  • Principal Investigator: Bernardo Cortese, MD, FESC, Ospedale Maggiore Policlinico, Milano, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2010

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

July 22, 2010

Last Update Submitted That Met QC Criteria

July 21, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bernard1

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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