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

NCT00825279 | Completed Phase 4 DMC

• 2 other identifiers: 02-CECIIMA 01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure

  six months

Secondary Outcomes (4)

• Stent thrombosis

  one year

• Paclitaxel allergy

  six months

• Cost-effectiveness

  one year

• Quantitative Coronary Angiography

  six months

Study Arms (2)

1-BMS

ACTIVE COMPARATOR

Bare Metal Stent (Euca STS Flex)

Device: Bare Metal Stent

2-DES

EXPERIMENTAL

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

Device: Drug Eluting Stent

Interventions

Bare Metal Stent DEVICE

Stainless steel stent

Also known as: Euca STS Flex

1-BMS

Drug Eluting Stent DEVICE

stent coated with the biodegradable polymer matrix hemoparin and paclitaxel

Also known as: Euca STS Flex DE

2-DES

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Centro de estudios en Cardiologia Intervencionista: lead
• Eucatech AG: collaborator

Study Sites (2)

Clinica IMA

Adrogué, Buenos Aires, 1846, Argentina

Location

Sanatorio Otamendi y Miroli

Buenos Aires, Buenos Aires, 1115, Argentina

Location

Related Publications (4)

• 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.

  PMID: 2950322 BACKGROUND

• 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.

  PMID: 8041413 BACKGROUND

• 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.

  PMID: 11297702 BACKGROUND

• 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.

  PMID: 20824769 DERIVED

Related Links

• German Cardiac Society
• Centro de Estudios en Cardiologia Intervencionista

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Alfredo E Rodriguez, MD, PHD

  Centro de estudios en Cardiologia Intervencionista

  STUDY CHAIR

• Carlos Fernandez-Pereira, MD

  Centro de estudios en Cardiologia Intervencionista

  STUDY DIRECTOR

• Alfredo E Rodriguez, MD, PHD

  Centro de Estudios en Cardiologia Internvencionista

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 21, 2009
• Study Start: August 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 28, 2010

Record last verified: 2010-05

Locations

AR (2)