A Prospective Multicenter Trial to Evaluate the Safety and Effectiveness of the ELANA Heart Bypass System in Patients undergoing Coronary Artery Bypass Grafting (SAFE-CAB)
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
The secondary effectiveness endpoint is defined as the graft patency. The
secondary effectiveness endpoint is measured at Study Visit 6 - POD 180.
Background summary
The ELANA Heart Bypass System is intended to be used for CABG either in an open
or a closed (minimally invasive) thorax. The technique is designed to create a
blood vessel anastomosis, on a beating heart, without blood flow occlusion and
without the use of any suturing.
The non-occlusive approach is easier to perform and therefore enables minimally
invasive CABG-procedures, ultimately reducing complication rates.
Study objective
A Prospective Multicenter Trial to Evaluate the Safety and Effectiveness of the
ELANA Heart Bypass System in Patients undergoing Coronary Artery Bypass
Grafting (SAFE-CAB)
Study design
The clinical investigation is designed as a prospective, single-arm,
multicenter trial.
The study will be conducted in 2 stages. In a First-in-Human (FIH) stage, 10
patients will be treated at 2 sites. A safety interim analysis will be
performed on these first 10 patients at post-operative day 30. Based on the
outcome of this interim analysis, the second stage will be initiated to recruit
an additional 65 patients in 2 sites to further evaluate safety and
effectiveness, in order to obtain the CE-mark for the device.
Intervention
Coronary Artery Bypass grafting with device implantation.
Study burden and risks
There are no additional burden to patients participating in the proposed study
when compared to the standard of care. As with any device undergoing clinical
investigation, there may be unforeseeable risks, which are not known at this
time. Medical and/or surgical intervention may be required to correct clinical
complications associated with the device procedure.
Anticipated benefits may be shorter surgery duration, non occlusive procedure
off pump, standardized anastomosis that is less dependent on the skill of the
surgeon.
Yalelaan 52
Utrecht 3584
NL
Yalelaan 52
Utrecht 3584
NL
Listed location countries
Age
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
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72738.100.20 |