Coronary Artery Disease Clinical Trial
— MARTINOfficial title:
A European Multicenter, Randomized, Single Blind Study of the MAR-Tyn Cobalt Chromium TiN-Coated Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions
The main objective of this study is to assess the safety and effectiveness of the TiN-coated MAR-Tyn stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to an uncoated control cobalt-chromium balloon-expandable stent (Vision, Abbott Vascular). Both stents are mounted on a Rapid Exchange Stent Delivery System.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | June 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients must meet ALL of the following criteria: 1. The patient must be > 18 years of age; 2. 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 3. 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; 4. 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; 5. Target vessel diameter at the lesion site is >2.50mm and <3.5mm in diameter (visual estimate); 6. Target lesion is >10mm and <22mm in length (visual estimate); 7. Target lesion stenosis is >50% and <100% (visual estimate); 8. At least TIMI II coronary flow; 9. Acceptable candidate for coronary artery bypass surgery (CABG); 10. Patient is willing to comply with the specified follow-up evaluation; 11. Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee. 12. 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 Exclusion Criteria: Patients will be excluded if ANY of the following conditions apply: 1. 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; 2. Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction; 3. Unprotected left main coronary disease with >50% stenosis; 4. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede runoff; 5. Have an ostial target lesion; 6. Have a target lesion in a venous graft; 7. Angiographic evidence of thrombus within target lesion; 8. Calcified lesion which cannot be successfully predilated; 9. Documented left ventricular ejection fraction <=25%; 10. Totally occluded vessel (TIMI 0 level); 11. Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment; 12. Pretreatment with devices other than balloon angioplasty; 13. Target lesion has excessive tortuousity or angulation (> 45°) which makes it unsuitable for stent delivery and deployment; 14. 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; 15. Prior stent within 5mm of target lesion; 16. Direct Stenting 17. Recipient of heart transplant; 18. Patient with a life expectancy less than 12 months; 19. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, cobalt, chromium, or contrast agent (that cannot be managed medically) 20. Recent (6 months) cerebrovascular accidents or intracranial hemorrhage 21. Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study; 22. Currently participating in an investigational drug or another device study; 23. Intervention of another lesion has occurred within 6 months before the index procedure; 24. In the investigator's opinion, the lesion is not suitable for stenting. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Department of Internal Medicine III (Cardiology), University of Freiburg im Breisgau | Freiburg Im Breisgau | |
Italy | Policlinico Universitario di Bari-Emodinamica Interventista | Bari | BA |
Italy | Ospedale San Raffaele- Emodinamica e Cardiologia | Milano | MI |
Italy | Ospedale di Ravenna, U.O. Cardiologia | Ravenna | Ra |
Italy | Campus Biomedico, Cardiologia | Roma | |
Netherlands | CARIM, Department of Cardiology | Maastricht | |
Switzerland | Cardiocentro Ticino, Cardiologia | Lugano |
Lead Sponsor | Collaborator |
---|---|
International Biomedical Systems S.p.A. |
Germany, Italy, Netherlands, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | in-stent minimum lumen diameter (MLD) | 6 months | No | |
Secondary | Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, thrombosis, or repeat target lesion revascularization | 30 days, 6 months, 12 months | Yes | |
Secondary | Angiographic binary restenosis (>50% diameter stenosis) 6 months post-procedure. In-lesion minimum lumen diameter (MLD) at 6 months post-procedure. | 6 months | No | |
Secondary | Target lesion revascularization (TLR) at 6 months post-procedure. Target vessel revascularization (TVR) at 6 months post-procedure. | 6 months | No | |
Secondary | • Device success defined as achievement of a final residual diameter stenosis of <30% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. | 6 months | No |
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