coronary artery disease stenosis
Conditions
Interventions
Patients will be randomized into either the MiStent DES or Endeavor DES arm of
the trial. This notification will be available through an interactive voice
response system (IVRS) to inform the site a
Sponsors
genae associates nv
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 1. Male and female patients of age >=18 years and 50% diameter stenosis; 7. If the patient has experienced a recent Q-wave (>72 hours) or non-Q-wave myocardial infarction, the CK, CK-MB levels should have returned to normal (
Exclusion criteria
Exclusion criteria: 1. Female patients of childbearing potential who = do not have a confirmed negative pregnancy test at baseline and are not on some form of birth control; 2. Recent Q-wave myocardial infarction occurred within 72 hours prior to the index procedure. 3. Recent Q-wave or non-Q-wave myocardial infarction with still elevated levels of cardiac markers (e.g. CK; and CK-MB if the CK is elevated); 4. Left ventricular ejection fraction 2.0 mg/dL or 177 µmol/L); 12. Platelet count 700,000 cells/mm³; 13. White blood cell count <3,000 cells/mm3; 14. Suspected or documented hepatic disease (including laboratorial evidence of hepatitis); 15. Heart transplant recipient; 16. Known contraindication to dual antiplatelet therapy (DAPT); 17. Known hypersensitivity to sirolimus (or its structurally related compounds), cobalt-chromium, or to medications such as aspirin, heparin and Angiomax® (bivalirudin), and all three of the following: clopidogrel bisulfate (Plavix), ticlopidine (Ticlid), and Prasugrel (Effient); 18. Concurrent medical condition with a life expectancy of less than 12 months; 19. Any major medical condition that, in the Investigator's opinion, may interfere with the optimal participation of the patient in this study; 20. Patient is currently participating in an investigational drug or another device study and has not completed the follow-up to the primary endpoint, or the patient in planning on participating in an investigational drug or another device study during the course of the present investigation prior to completing 12-months follow-up; 21. Target vessel has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) or within a year prior to index procedure; 22. Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter prior to stent placement; 23. Patient previously treated at any time with coronary intravascular brachytherapy; 24. Planned coronary angioplasty (with or without stenting) or CABG in the first 9 months after the index procedure or any other planned intervention within 30 days post index procedure; 25. Prior PCI of a non-target vessel must be at least 14 days prior to study enrollment; 26. The intent to direct stent the target lesion; 27. Angiographic Exclusion Criteria: To be assessed at the time of the index procedure catheterization prior to randomization and stent placement using visual estimate or online QCA, as appropriate; 27.1 In-stent restenotic target lesion; 27.2 More than one lesion requiring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint: The primary endpoint is in-stent late lumen loss (LLL) measured by the angiographic core laboratory and calculated as a difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up. Angiographic analysis will be performed at 9 months. Primary Safety Endpoint: The primary safety endpoint for this trial is the rate of Major Adverse Cardiac Events (MACE) defined as death, MI and target vessel revascularization (TVR) at 9 months post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: 1. Device success defined as stent deployment resulting in a final percentage diameter stenosis (DS) of less than or equal to 30% using the assigned stent; 2. Lesion success defined as attainment of | — |
Countries
Netherlands
Outcome results
None listed