Heart bypass surgery
Conditions
Interventions
Coronary Artery Bypass grafting with device implantation.
Sponsors
AMT Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide voluntary written Informed Consent and sign the ICF to participate in the study prior to any study related procedure, 2. Is 18 years or older, 3. Assigned for CABG by the cardiologist and/or cardiothoracic surgeon with one or more vessel disease including the left anterior descending coronary artery (LAD), 4. Agrees to attend all follow-up assessments for up to 2 years and is willing to comply with specified follow-up evaluations at clinical investigational sites and/or obtain all protocol-specified diagnostic tests
Exclusion criteria
Exclusion criteria: 1. Patient is unlikely to cooperate or is legally incompetent, including patients who are institutionalized by court or official order, 2. Any condition which could interfere with the patient’s ability to comply with the study, 3. Ongoing participation in any other interventional clinical study, 4. Female patients who are pregnant or lactating, 5. Females who are of child-bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child-bearing potential taking acceptable contraceptive precautions can be included, Note: A highly effective method of birth control and one which is acceptable for this study, is defined as one that can achieve a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. 6. History of cardiothoracic surgery 7. Active smokers, 8. Patients with LVEF<30, 9. Concomitant cardiothoracic procedures (i.e. rhythm, aortic, valve surgery, etc.) 10. Requires a planned therapeutic, interventional, or surgical procedure within 1 month (30 days) before or after the scheduled index procedure, 11. Chronic or acute renal failure requiring renal replacement therapy, 12. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to scheduled index procedure, 13. History of bleeding disorders or coagulopathies, 14. Contradicted for LITA harvesting (i.e. obstruction / aortoiliac occlusive disease / radiation therapy at the thoracic region). ). For SAFE-CAB III, contraindications for additional artery harvesting (RITA or RA) are also considered, such as negative Allen test, 15. Need for urgent and/or emergent surgery for any reason, 16. During the operation, patients can still be excluded from the study in accordance to the instructions of use for the ELANA Heart Bypass
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint is defined as the proportion of patients free from all Major Adverse Cardiac Events (MACEs) at Study Visit 7 – POD 365. MACE is a composite safety parameter that includes the following events: • Cardiac related mortality, • Myocardial Infarction, • Repeated LAD revascularization. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary effectiveness endpoint is defined as the graft patency. The secondary effectiveness endpoint is measured at Study Visit 6 – POD 180. | — |
Countries
Netherlands
Contacts
Public ContactPascal Winnen
HEMEX
Outcome results
None listed