elixir medical clinical evaluation of the desolve myolimus eluting bioresorbable coronary stent system - desolve i trial

Conditions: Coronary Artery Disease

Summary: this prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, type a lesions \< 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline qca and ivus. all patients will receive a 3.0 x 14mm desolve stent loaded with approximately 40 mcg of myolimus. * angiographic and intravascular ultrasound (ivus) will be completed for all patients at baseline and at 6 months. * optical coherence tomography (oct) will will be completed for all patients at baseline and at 6 months. * multi-slice computed tomography (msct) will be conducted on all patients enrolled at 12 and 24 months.


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 \ 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)

Keywords: coronary artery disease