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

NCT ID: NCT00825279

Last Updated: 2010-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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Biodegradable polymer Drug Eluting Stent In stent restenosis stent thrombosis Bare Metal Stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1-BMS

Bare Metal Stent (Euca STS Flex)

Group Type ACTIVE_COMPARATOR

Bare Metal Stent

Intervention Type DEVICE

Stainless steel stent

2-DES

Drug Eluting Stent (Euca STS Flex DE), Paclitaxel Eluting stent with biodegradable polymer

Group Type EXPERIMENTAL

Drug Eluting Stent

Intervention Type DEVICE

stent coated with the biodegradable polymer matrix hemoparin and paclitaxel

Interventions

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Bare Metal Stent

Stainless steel stent

Intervention Type DEVICE

Drug Eluting Stent

stent coated with the biodegradable polymer matrix hemoparin and paclitaxel

Intervention Type DEVICE

Other Intervention Names

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Euca STS Flex Euca STS Flex DE

Eligibility Criteria

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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%)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eucatech AG

INDUSTRY

Sponsor Role collaborator

Centro de estudios en Cardiologia Intervencionista

OTHER

Sponsor Role lead

Responsible Party

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Centro de Estudios en Cardiologia Intervencionista

Principal Investigators

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Alfredo E Rodriguez, MD, PHD

Role: STUDY_CHAIR

Centro de estudios en Cardiologia Intervencionista

Carlos Fernandez-Pereira, MD

Role: STUDY_DIRECTOR

Centro de estudios en Cardiologia Intervencionista

Alfredo E Rodriguez, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Centro de Estudios en Cardiologia Internvencionista

Locations

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Clinica IMA

Adrogué, Buenos Aires, Argentina

Site Status

Sanatorio Otamendi y Miroli

Buenos Aires, Buenos Aires, Argentina

Site Status

Countries

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Argentina

References

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Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.

Reference Type BACKGROUND
PMID: 2950322 (View on PubMed)

Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.

Reference Type BACKGROUND
PMID: 8041413 (View on PubMed)

Serruys PW, Unger F, Sousa JE, Jatene A, Bonnier HJ, Schonberger JP, Buller N, Bonser R, van den Brand MJ, van Herwerden LA, Morel MA, van Hout BA; Arterial Revascularization Therapies Study Group. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med. 2001 Apr 12;344(15):1117-24. doi: 10.1056/NEJM200104123441502.

Reference Type BACKGROUND
PMID: 11297702 (View on PubMed)

Rodriguez AE, Vigo CF, Delacasa A, Mieres J, Fernandez-Pereira C, Bernardi V, Bettinoti M, Rodriguez-Granillo AM, Rodriguez-Granillo G, Santaera O, Curotto V, Rubilar B, Tronge J, Palacios IF, Antoniucci D; EUCATAX Investigators. Efficacy and safety of a double-coated paclitaxel-eluting coronary stent: the EUCATAX trial. Catheter Cardiovasc Interv. 2011 Feb 15;77(3):335-42. doi: 10.1002/ccd.22769. Epub 2010 Nov 30.

Reference Type DERIVED
PMID: 20824769 (View on PubMed)

Related Links

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http://www.dgk.org

German Cardiac Society

http://www.centroceci.com.ar

Centro de Estudios en Cardiologia Intervencionista

Other Identifiers

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02-CECI

Identifier Type: -

Identifier Source: secondary_id

IMA 01

Identifier Type: OTHER

Identifier Source: secondary_id

02-CECI

Identifier Type: -

Identifier Source: org_study_id