ischemic heart disease
Conditions
Interventions
Before the procedure, the patient will have some blood drawn for tests and an
electrocardiogram (ECG).
As part of the stent placement procedure, the investigator will take pictures
of the coronary
Sponsors
Medlogics Device Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. The subject is >= 18 years old; 2. Subject is eligible for percutaneous coronary intervention (PCI), stent placement, and emergent coronary artery bypass graft (CABG) surgery; 3. Subject has clinical evidence of ischemic heart disease, stable or unstable angina or silent ischemia; 4. The subject has a documented left ventricular ejection fraction (LVEF) >= 30%; 5. The subject or legal representative has been informed of the clinical study and the required follow-up procedures and must provide written informed consent using a form that is reviewed and approved by the Institutional Review Board/Ethics Committee (IRB/EC) for the clinical site; 6. Female subjects of childbearing potential must have a negative pregnancy test within 7 days before treatment; 7. Subject must agree to comply with the required follow-up procedures (including antiplatelet regimen) to the best of their ability, be geographically available for all study follow-up procedures and visits and not have a known medical condition that precludes completion of the required follow-up visits.;Angiographic Inclusion Criteria: 8. The lesion is either de novo or restenotic (previously unstented) in nature, located in a native coronary artery AND is >= 50% and = 2.5mm and = 2.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. The subject has a known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, ticlopidine and clopidogrel, cobalt, nickel, chromium, molybdenum, or a sensitivity to contrast media, which cannot be adequately pre-medicated; 2. A platelet count 700,000 cells/mm³, or a WBC 2.5 mg/dL within 7 days prior to the index procedure; 4. Evidence of an acute myocardial infarction (MI) within 72 hours of the intended treatment (defined as: Q wave (QWMI) or any elevation of creatine kinase myocardial-band (CKMB) isoenzyme elevated above the Institution's upper limit of normal; 5. Any previous PCI (with or without stent) of the target vessel within 30 days prior to the index procedure; 6. Previous stent placement anywhere in the target lesion; 7. Previous drug eluting stent (DES) deployment anywhere in the target vessel; 8. The subject requires staged procedure of any non-target vessel within 30 days postprocedure; 9. The subject requires staged procedure of the target vessel within 9 months postprocedure; 10. The target lesion requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.); 11. History of a stroke or transient ischemic attack (TIA) within the previous 6 months; 12. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the previous 6 months; 13. History of bleeding diathesis or coagulopathy or will refuse blood transfusions; 14. A known concurrent medical condition resulting in a life expectancy of less than 12 months; 15. Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy; 16. The subject is currently participating in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial; or interferes with the current trial endpoints; or the subject has previously been enrolled in the study; 17. The subject has a known medical condition that will cause them to be non-compliant with the study protocol or confound the data interpretation.;Angiographic Exclusion Criteria: 18. The target vessel has evidence of thrombus or other lesions having a > 60% stenosis by visual estimate or on-line QCA; 19. Target vessel exhibiting multiple lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA; 20. The target vessel has evidence (visual or QCA) of excessive tortuosity (two or more 90° bends prior to the target lesion) or is severely calcified; 21. The target lesion is in an unprotected left main, involves a side branch vessel having a diameter of > 2.0 mm or is at the aorto-ostial location.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety and effectiveness endpoint for this study is target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Major Adverse Cardiac Events (MACE): defined as cardiac death, MI, emergent bypass surgery, or clinically driven target lesion revascularization (TLR) at 30, 180 and 270 days 2. TVF at 30 and 180 days 3. Acute Success Rates: a. Device Success: Attainment of 50% of the reference vessel diameter) f. In-stent binary restenosis g. In-stent minimum lumen diameter (MLD) | — |
Countries
Netherlands
Outcome results
None listed