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)
- Conditions
- Coronary Artery DiseaseHeart Attack10011082
- Registration Number
- NL-OMON56444
- Lead Sponsor
- AMT Medical B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 92
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.
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),
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary safety endpoint is defined as the proportion of patients free from<br /><br>all Major Adverse Cardiac Events (MACEs) at Study Visit 7 - POD 365.<br /><br>MACE is a composite safety parameter that includes the following events:<br /><br>• Cardiac related mortality,<br /><br>• Myocardial Infarction,<br /><br>• Repeated LAD revascularization.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary effectiveness endpoint is defined as the graft patency. The<br /><br>secondary effectiveness endpoint is measured at Study Visit 6 - POD 180. </p><br>