CLINICAL INVESTIGATION OF A DES (MISTENT* SYSTEM) WITH SIROLIMUS AND A BIOABSORBABLE POLYMER FOR THE TREATMENT OF PATIENTS WITH DE NOVO LESIONS IN NATIVE CORONARY ARTERIES
- Conditions
- coronary artery diseasestenosis10011082
- Registration Number
- NL-OMON36775
- Lead Sponsor
- genae associates nv
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. 1. Male and female patients of age >=18 years and <=85 years;
2. Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia;
3. Planned single, de novo, types A, B1 or B2 coronary lesions (according to the ACC/AHA classification);
4. Target lesion located in a native coronary artery;
5. Target lesion in vessel with diameter ranging from 2.5 to 3.5 mm amenable to treatment (coverage) with a maximum 30 mm long stent;
6. Target lesion with >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 (8. Patients who are eligible for percutaneous coronary intervention (PCI);
9. Acceptable candidate for myocardial revascularization surgery (coronary artery bypass graft surgery);
10. A patient may have one additional critical non-target lesion. The target lesion is the only lesion that must meet the study inclusion requirements. The non-target lesion may be treated at the time of the index procedure but must be successfully treated without complications before the target lesion. The non-target lesion will not be considered to be part of the study and does not require the follow-up evaluations defined in the protocol. If more than one lesion meets the inclusion criteria, only one lesion/vessel chosen by the Investigator should be treated with the study stent; the other lesion(s) should be treated outside the study with approved devices. An approved bare metal stent or another commercially available *limus* based DES product may be used in the non-target vessel.
11. The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.
12. The patient is affiliated with a social security system (if required by individual country regulations).
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 <30% (within the previous 6-months);
5. Patients in cardiogenic shock;
6. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months;
7. Active GI bleeding within past three months;
8. Any prior true anaphylactic reaction to contrast agents;
9. Patient is receiving or scheduled to receive chemotherapy within 30-days before or after the index procedure;
10. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus);
11. Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);
12. Platelet count <100,000 cells/mm³ or >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Endpoint: The primary endpoint is in-stent late lumen loss<br /><br>(LLL) measured by the angiographic core laboratory and calculated as a<br /><br>difference between the post-procedure minimal lumen diameters (MLD) in the<br /><br>treated segment (stented region) minus the MLD in the same region at<br /><br>follow-up. Angiographic analysis will be performed at 9 months.<br /><br><br /><br>Primary Safety Endpoint: The primary safety endpoint for this trial is the<br /><br>rate of Major Adverse Cardiac Events (MACE) defined as death, MI and target<br /><br>vessel revascularization (TVR) at 9 months post-procedure. </p><br>
- Secondary Outcome Measures
Name Time Method