Last updated on February 2010

European Multicenter Randomized Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Stents | Transluminal | Coronary Artery Disease | Percutaneous Coronary | Angioplasty
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Patients must meet ALL of the following criteria:
    The patient must be > 18 years of age;
    Female of childbearing potential must have a negative pregnancy test within 7 days of
    enrollment and utilize reliable birth control for eight months after enrollment
    Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society
    Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald
    Classification B&C, I-II) OR patients with documented silent ischemia;
    Single treatment of de novo lesion in a major coronary artery in patients with single
    or multi-vessel disease; patients with multiple lesions can be included only if the
    other lesions do not require treatment;
    Target vessel diameter at the lesion site is >2.50mm and <3.5mm in diameter (visual
    Target lesion is >10mm and <22mm in length (visual estimate);
    Target lesion stenosis is >50% and <100% (visual estimate);
    At least TIMI II coronary flow;
    Acceptable candidate for coronary artery bypass surgery (CABG);
    Patient is willing to comply with the specified follow-up evaluation;
    Patient must provide written informed consent prior to the procedure using a form
    that is approved by the local Ethics Committee.
    Patient can be pre-treated with aspirin and clopidogrel or, alternatively, aspirin
    alone plus a loading dose of 300 mg of clopidogrel before procedure completion in
    case of urgent PCI

You may not be eligible for this study if the following are true:

  • Patients will be excluded if ANY of the following conditions apply:
    Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented
    total CK >2 times normal within the preceding 24 hours and the CK and CK-MB enzymes
    remains above normal at the time of treatment;
    Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a
    peri infarction;
    Unprotected left main coronary disease with >50% stenosis;
    Significant (>50%) stenosis proximal or distal to the target lesion that might
    require revascularization or impede runoff;
    Have an ostial target lesion;
    Have a target lesion in a venous graft;
    Angiographic evidence of thrombus within target lesion;
    Calcified lesion which cannot be successfully predilated;
    Documented left ventricular ejection fraction <=25%;
    Totally occluded vessel (TIMI 0 level);
    Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
    Pretreatment with devices other than balloon angioplasty;
    Target lesion has excessive tortuousity or angulation (> 45°) which makes it
    unsuitable for stent delivery and deployment;
    Target lesion involves bifurcation including a diseased side branch >=2 mm in
    diameter (either stenosis of both main vessel and major branch or stenosis of just
    major branch) that would require side branch stenting;
    Prior stent within 5mm of target lesion;
    Direct Stenting
    Recipient of heart transplant;
    Patient with a life expectancy less than 12 months;
    Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and
    ticlopidine (Ticlid), heparin, cobalt, chromium, or contrast agent (that cannot be
    managed medically)
    Recent (6 months) cerebrovascular accidents or intracranial hemorrhage
    Any significant medical condition which in the investigator's opinion may interfere
    with the patient's optimal participation in the study;
    Currently participating in an investigational drug or another device study;
    Intervention of another lesion has occurred within 6 months before the index
    In the investigator's opinion, the lesion is not suitable for stenting.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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