Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial

Elixir Medical

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Study type

Interventional

Funder types

Industry

Identifiers

NCT02086006

ELX-CL-1002

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)