Status:
UNKNOWN
European Multicenter, Randomized, Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent
Lead Sponsor:
International Biomedical Systems S.p.A.
Conditions:
Coronary Artery Disease
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 t...
Detailed Description
Occlusive coronary artery disease is predominantly caused by coronary atherosclerosis, a pathologic vascular condition characterized by abnormal lipid and fibrous tissue accumulation in the vessel wal...
Eligibility Criteria
Inclusion
- 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 estimate);
- 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
Exclusion
- 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 procedure;
- In the investigator's opinion, the lesion is not suitable for stenting.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00637104
Start Date
July 1 2008
End Date
June 1 2011
Last Update
February 9 2010
Active Locations (7)
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1
Department of Internal Medicine III (Cardiology), University of Freiburg im Breisgau
Freiburg im Breisgau, Germany, 79106
2
Policlinico Universitario di Bari-Emodinamica Interventista
Bari, BA, Italy
3
Ospedale San Raffaele- Emodinamica e Cardiologia
Milan, MI, Italy
4
Ospedale di Ravenna, U.O. Cardiologia
Ravenna, Ra, Italy