I25 - Ischemic heart diseases
Conditions
Interventions
Group 1: To evaluate the safety and effectiveness of the ELANA Heart Bypass system. The ELANA Heart Bypass System is intended to be used for CABG either in an open or a closed (minimally invasive) tho
Sponsors
AMT Medical
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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: Patients meeting any of the following criteria at Study Visit 1: Day of Screening / Enrolment will be excluded from entry into the study: 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 vasectomize
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety in terms of MACES (Major Adverse Cardiac Events) at the end of one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Graft patency at 6-months post surgery. | — |
Countries
Netherlands
Contacts
Public ContactGlenn Bronkers
AMT Medical
Outcome results
None listed