Trial Between a Paclitaxel Eluting Stent With Biodegradable Polymer Versus Bare Metal Stent - Full Text View

Sponsors and Collaborators:	Centro de estudios en Cardiologia Intervencionista Eucatech AG
Information provided by:	Centro de estudios en Cardiologia Intervencionista
ClinicalTrials.gov Identifier:	NCT00825279

Purpose

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 differents kind of drugs that prevents 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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Bare Metal Stent Device: Drug Eluting Stent	Phase IV

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparision Among a Paclitaxel Eluting Stent With Biodegradable Polymer Versus an Uncoated Bare Metal Stent. A Prospective, Multicentric and Randomized Study.(EUCATAX Trial)

Further study details as provided by Centro de estudios en Cardiologia Intervencionista:

Primary Outcome Measures:

Target Vessel Failure [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Stent thrombosis [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Paclitaxel allergy [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Cost-effectiveness [ Time Frame: one year ] [ Designated as safety issue: No ]
Quantitative Coronary Angiography [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Bare Metal Stent (Euca STS Flex)	Device: Bare Metal Stent Stainless steel stent
2: Experimental Drug Eluting Stent (Euca STS Flex DE)	Device: Drug Eluting Stent stent coated with the biodegradable polymer matrix hemoparin and paclitaxel

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 of 2.5 to 4.0 mm

Exclusion Criteria:

Female patients of child bearing age with pregnancy suspcion(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 ,
Substancially 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 Aspirine or unable to receive clopidogrel for one year,
Active duodenal or gastric ulcer,
Life Expectancy less than 1 year,
Patient with LM disease (>50%)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825279

Contacts

Contact: Alfredo E Rodriguez, MD, PHD	541149648721	rodrigueza@sanatorio-otamendi.com.ar
Contact: Carlos Fernandez-Pereira, MD	541149638888 ext 190	cfernandezpereira@centroceci.com.ar

Locations

Argentina
Sanatorio Otamendi y Miroli	Recruiting
Buenos Aires, Argentina, 1115
Contact: Alfredo E Rodriguez, MD, PHD 541149648721 rodrigueza@sanatorio-otamendi.com.ar
Sub-Investigator: Alfredo Matias Rodriguez-Granillo
Sub-Investigator: Juan Mieres, MD
Principal Investigator: Alfredo E Rodriguez, MD, PHD
Argentina, Buenos Aires
Clinica IMA	Recruiting
Adrogue, Buenos Aires, Argentina, 1846
Contact: Carlos Fernandez-Pereira, MD 541142145555 ext 193 cfernandezpereira@centroceci.com.ar
Sub-Investigator: Gilberto Perez, MD
Sub-Investigator: Bibiana N Rubilar, MD

Sponsors and Collaborators

Centro de estudios en Cardiologia Intervencionista

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

More Information

Additional Information:

German Cardiac Society This link exits the ClinicalTrials.gov site

Centro de Estudios en Cardiologia Intervencionista This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Serruys PW, Unger F, Sousa JE, Jatene A, Bonnier HJ, Schönberger 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.

Responsible Party:	Centro de Estudios en Cardiologia Intervencionista ( Alfredo E Rodriguez, MD, PHD, FACC, FSCAI )
Study ID Numbers:	02-CECI, 02-CECI
Study First Received:	January 20, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00825279 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Centro de estudios en Cardiologia Intervencionista:

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Antimitotic Agents

Thrombosis
Coronary Disease
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myocardial Ischemia
Mitosis Modulators
Vascular Diseases
Arteriosclerosis
Antimitotic Agents

Pharmacologic Actions
Coronary Disease
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Cardiovascular Diseases
Antineoplastic Agents, Phytogenic
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009