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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Bare Metal Stent; Device: Drug Eluting Stent

• Registration Number: NCT00825279
• Lead Sponsor: Centro de estudios en Cardiologia Intervencionista

Brief 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.

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-27
• Last Update Posted: 2010-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-BMS	Bare Metal Stent	Bare Metal Stent (Euca STS Flex)
2-DES	Drug Eluting Stent	Drug Eluting Stent (Euca STS Flex DE), Paclitaxel Eluting stent with biodegradable polymer

Primary Outcome Measures

Name	Time	Method
Target Vessel Failure	six months

Secondary Outcome Measures

Name	Time	Method
Stent thrombosis	one year
Paclitaxel allergy	six months
Cost-effectiveness	one year
Quantitative Coronary Angiography	six months

Trial Locations

Locations (2)

Clinica IMA; 🇦🇷 Adrogue, Buenos Aires, Argentina

Sanatorio Otamendi y Miroli; 🇦🇷 Buenos Aires, Argentina