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

Coronary Artery Disease Clinical Trial

— EUCATAX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825279
• Other study ID #: 02-CECI
• Secondary ID: 02-CECIIMA 01
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2009
• Last updated: May 27, 2010
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2010
• Source: Centro de estudios en Cardiologia Intervencionista
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Bare Metal Stent
Stainless steel stent
• Drug Eluting Stent
stent coated with the biodegradable polymer matrix hemoparin and paclitaxel

Locations

Country	Name	City	State
Argentina	Clinica IMA	Adrogue	Buenos Aires
Argentina	Sanatorio Otamendi y Miroli	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Centro de estudios en Cardiologia Intervencionista	Eucatech AG

Country where clinical trial is conducted

Argentina, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Failure		six months	Yes
Secondary	Stent thrombosis		one year	Yes
Secondary	Paclitaxel allergy		six months	Yes
Secondary	Cost-effectiveness		one year	No
Secondary	Quantitative Coronary Angiography		six months	No

External Links

•   Centro de Estudios en Cardiologia Intervencionista
•   German Cardiac Society