Back to resultsA Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent (EUCATAX)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Bare Metal Stent
Drug Eluting Stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Biodegradable polymer, Drug Eluting Stent, In stent restenosis, stent thrombosis, Bare Metal Stent
Eligibility 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 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%)
Sites / Locations
- Clinica IMA
- Sanatorio Otamendi y Miroli
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1-BMS
2-DES
Arm Description
Bare Metal Stent (Euca STS Flex)
Drug Eluting Stent (Euca STS Flex DE), Paclitaxel Eluting stent with biodegradable polymer
Outcomes
Primary Outcome Measures
Target Vessel Failure
Secondary Outcome Measures
Stent thrombosis
Paclitaxel allergy
Cost-effectiveness
Quantitative Coronary Angiography
Full Information
NCT ID
NCT00825279
First Posted
January 20, 2009
Last Updated
May 27, 2010
Sponsor
Centro de estudios en Cardiologia Intervencionista
Collaborators
Eucatech AG
1. Study Identification
Unique Protocol Identification Number
NCT00825279
Brief Title
A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centro de estudios en Cardiologia Intervencionista
Collaborators
Eucatech AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Biodegradable polymer, Drug Eluting Stent, In stent restenosis, stent thrombosis, Bare Metal Stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1-BMS
Arm Type
Active Comparator
Arm Description
Bare Metal Stent (Euca STS Flex)
Arm Title
2-DES
Arm Type
Experimental
Arm Description
Drug Eluting Stent (Euca STS Flex DE), Paclitaxel Eluting stent with biodegradable polymer
Intervention Type
Device
Intervention Name(s)
Bare Metal Stent
Other Intervention Name(s)
Euca STS Flex
Intervention Description
Stainless steel stent
Intervention Type
Device
Intervention Name(s)
Drug Eluting Stent
Other Intervention Name(s)
Euca STS Flex DE
Intervention Description
stent coated with the biodegradable polymer matrix hemoparin and paclitaxel
Primary Outcome Measure Information:
Title
Target Vessel Failure
Time Frame
six months
Secondary Outcome Measure Information:
Title
Stent thrombosis
Time Frame
one year
Title
Paclitaxel allergy
Time Frame
six months
Title
Cost-effectiveness
Time Frame
one year
Title
Quantitative Coronary Angiography
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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 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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo E Rodriguez, MD, PHD
Organizational Affiliation
Centro de estudios en Cardiologia Intervencionista
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Fernandez-Pereira, MD
Organizational Affiliation
Centro de estudios en Cardiologia Intervencionista
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alfredo E Rodriguez, MD, PHD
Organizational Affiliation
Centro de Estudios en Cardiologia Internvencionista
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica IMA
City
Adrogue
State/Province
Buenos Aires
ZIP/Postal Code
1846
Country
Argentina
Facility Name
Sanatorio Otamendi y Miroli
City
Buenos Aires
ZIP/Postal Code
1115
Country
Argentina
12. IPD Sharing Statement
Citations:
PubMed Identifier
2950322
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. doi: 10.1056/NEJM198703193161201.
Results Reference
background
PubMed Identifier
8041413
Citation
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.
Results Reference
background
PubMed Identifier
11297702
Citation
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.
Results Reference
background
PubMed Identifier
20824769
Citation
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.
Results Reference
derived
Links:
URL
http://www.dgk.org
Description
German Cardiac Society
URL
http://www.centroceci.com.ar
Description
Centro de Estudios en Cardiologia Intervencionista
Learn more about this trial
A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent
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