A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent (EUCATAX)

May 27, 2010 updated by: Centro de estudios en Cardiologia Intervencionista

Comparison Among a Paclitaxel Eluting Stent With Biodegradable Polymer Versus an Uncoated Bare Metal Stent. A Prospective, Multicentric and Randomized Study.(EUCATAX Trial)

The success of stent implantation has led to the increasingly widespread use of them in the treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation of stents with improved coating materials and the development of polymers that release different kinds of drugs that prevent the activation and/or proliferation of smooth muscle cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this matter. The new generation of stents with biodegradable polymers and short time of drug release gives new advantages to this therapeutic, multiple studies and registries challenge this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III).

For this reason the present study aims to compare a stainless steel stent with a drug eluting stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with a stainless steel stent ("euca STS Flex") or a drug-eluting stent (" euca STS Flex DE") with a coating of a biodegradable polymer matrix of hemoparin and paclitaxel.

Study Type

Interventional

Enrollment (Actual)

300

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

  • Argentina
      • Buenos Aires, Argentina, 1115
        • Sanatorio Otamendi y Miroli
    • Buenos Aires
      • Adrogue, Buenos Aires, Argentina, 1846
        • Clinica IMA

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:

  • Patient signing informed consent after receiving extensive written and oral information about the trial,
  • Older than 18 years,
  • Agreement to have a control examination done after six months,
  • Patients with angina pectoris symptoms (CCS stages i-IV, unstable angina pectoris Braunwald B and C) and patients with documented silent ischemia;
  • Patients with one or more de novo lesions which all are to be dilated in the same session;
  • Target vessel diameter of 2.5 to 4.0 mm

Exclusion Criteria:

  • Female patients of child bearing age with pregnancy suspicion(a pregnancy test will be done in this cases)
  • Acute myocardial infarction (Q wave or non Q wave ) with documented CK levels more than 2 fold higher than the normal values in the preceding 72 hours ,
  • Substantially calcified lesion precluding successful pre dilatation,
  • Ejection Fraction less than 35%,
  • Patient with previous PCI with one DES,
  • Target lesion < 2.5 mm
  • Coagulopathy or clotting disorders, leucopenia anemia or thrombocytopenia,
  • Allergy, hypersensitivity or adverse reaction to paclitaxel,
  • Intolerance to the clopidogrel, Ticlopidine or Aspirin or unable to receive clopidogrel for one year,
  • Active duodenal or gastric ulcer,
  • Life Expectancy less than 1 year,
  • Patient with LM disease (>50%)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1-BMS
Bare Metal Stent (Euca STS Flex)
Device: Bare Metal Stent
Stainless steel stent
Other Names:
  • Euca STS Flex
Experimental: 2-DES
Drug Eluting Stent (Euca STS Flex DE), Paclitaxel Eluting stent with biodegradable polymer
Device: Drug Eluting Stent
stent coated with the biodegradable polymer matrix hemoparin and paclitaxel
Other Names:
  • Euca STS Flex DE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target Vessel Failure
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Stent thrombosis
Time Frame: one year
one year
Paclitaxel allergy
Time Frame: six months
six months
Cost-effectiveness
Time Frame: one year
one year
Quantitative Coronary Angiography
Time Frame: six months
six months

Collaborators and Investigators

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

Sponsor

Centro de estudios en Cardiologia Intervencionista

Collaborators

Eucatech AG

Investigators

  • Study Chair: Alfredo E Rodriguez, MD, PhD, Centro de Estudios en Cardiologia Intervencionista
  • Study Director: Carlos Fernandez-Pereira, MD, Centro de Estudios en Cardiologia Intervencionista
  • Principal Investigator: Alfredo E Rodriguez, MD, PHD, Centro de Estudios en Cardiologia Internvencionista

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

Helpful Links

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

August 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-CECI
  • IMA 01 (Other Identifier: Clinica IMA, Buenos Aires, Argentina)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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