NL-OMON56444RecruitingNot Applicable
A Prospective Multicenter Trial to Evaluate the Safety and Effectiveness of the ELANA Heart Bypass System in Patients undergoing Coronary Artery Bypass Grafts (SAFE-CAB) - SAFE-CAB
AMT Medical B.V.0 sites92 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 92
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
- •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,
- •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),
- •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
Investigators
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