NL-OMON36775
Completed
Phase 2
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 - DESSOLVE II
genae associates nv0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- coronary artery disease
- Sponsor
- genae associates nv
- Enrollment
- 50
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
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 \<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);
Outcomes
Primary Outcomes
Not specified
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