Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT02086006
Eligibility Criteria:
Inclusion Criteria:
* Patient must be at least 18 years of age
* Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve Myolimus Eluting BCSS and he/she or his/her legally authorized representative provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure
* Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study electrocardiogram (ECG) changes consistent with ischemia)
* Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
* Patient must agree to undergo all clinical study required follow-up visits, angiograms, IVUS, OCT and MSCT
* Patient must agree not to participate in any other clinical study for a period of two years following the index procedure
Exclusion Criteria:
* Patients has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
* The patient is currently experiencing clinical symptoms consistent with AMI
* Patient has current unstable arrhythmias Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or target vessel Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or target vessel
* Patient has a known left ventricular ejection fraction (LVEF) \< 30%
* Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
* Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
* Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
* Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
* Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Myolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
* Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
* Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease.
* Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
* Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
* Patient has had a significant GI or urinary bleed within the past six months
* Patient has extensive peripheral vascular disease that precludes safe 7 French sheath insertion
* Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
* Patient is already participating in another clinical study
* Women of childbearing potential who have not undergone surgical sterilization or is not post-menopausal (defined as amenorrheic for at least one year)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02086006
Study Brief:
Protocol Section:
NCT02086006