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Coronary Artery DiseasePhase 4EUCATAXNCT00825279

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

A Phase 4 study testing Bare Metal Stent and Drug Eluting Stent in people with Coronary Artery Disease, run by Centro de estudios en Cardiologia Intervencionista at 2 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Bare Metal Stent and Drug Eluting Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesArgentina
Study dates
Aug 2007to Aug 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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%)

Trial locations and contacts

2 sites in 1 country.

Argentina2 sites

  • Clinica IMA

    Adrogué, Buenos Aires, 1846

  • Sanatorio Otamendi y Miroli

    Buenos Aires, Buenos Aires, 1115

Other trials in Argentina

About this study

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)

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.

Read the 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.

Being tested
Bare Metal Stent, Drug Eluting Stent
Keywords
Biodegradable polymer, Drug Eluting Stent, In stent restenosis, stent thrombosis, Bare Metal Stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bare Metal StentDevice

    Also called Euca STS Flex

    Stainless steel stent

  • Drug Eluting StentDevice

    Also called Euca STS Flex DE

    stent coated with the biodegradable polymer matrix hemoparin and paclitaxel

Study groups in NCT00825279
Study groupRoleWhat they receive
1-BMSActive comparatorBare Metal Stent (Euca STS Flex)
Receives: Device: Bare Metal Stent
2-DESExperimentalDrug Eluting Stent (Euca STS Flex DE), Paclitaxel Eluting stent with biodegradable polymer
Receives: Device: Drug Eluting Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Vessel Failure

    Measured: six months

Secondary outcomes (4)

  1. Stent thrombosis

    Measured: one year

  2. Paclitaxel allergy

    Measured: six months

  3. Cost-effectiveness

    Measured: one year

  4. Quantitative Coronary Angiography

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2009 (estimated)
  2. Study startAug 2007
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00825279
Sponsor's protocol ID
02-CECI
Other IDs
02-CECI, IMA 01
Acronym
EUCATAX
Status last verified
May 2010
First submitted
20 Jan 2009
Last updated
28 May 2010
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1056/NEJM198703193161201.

    PubMed 2950322

  • 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.

    PubMed 8041413

  • 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.

    PubMed 11297702

  • 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.

    PubMed 20824769

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bare Metal Stent and Drug Eluting Stent in people with Coronary Artery Disease, run by Centro de estudios en Cardiologia Intervencionista at 2 sites in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel Failure (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00825279, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2010; AzTrials last refreshed its copy on 31 Oct 2026.

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