Coronary Artery Bypass Grafting (CABG) SurgeryMULTI-CABNCT07005843
A Study Testing the Elana Device for Multi-Artery Heart Bypass Surgery
A study testing The Elana Anastomotic System in people with Coronary Artery Bypass Grafting (CABG) Surgery, run by AMT Medical BV at 1 site in Netherlands.
Trial summary
The purpose of the trial is to evaluate the feasibility and safety of multiple Elana Anastomotic Systems to anastomose multiple arterial grafts during coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting (CABG) Surgery
- What is being tested?
- The Elana Anastomotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Sep 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide voluntary written Informed Consent and sign the Informed Consent Form to participate in the study prior to any study-related procedure,
- Is 18 years or older,
- Assigned for CABG by the cardiologist and/or cardiothoracic surgeon with one or more vessel disease requiring multiple distal anastomoses, including one on the left anterior descending coronary artery (LAD),
- 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.
Who cannot join
- Patient is unlikely to cooperate or is legally incompetent, including patients who are institutionalized by court or official order,
- Any condition which could interfere with the patient's ability to comply with the study,
- Ongoing participation in any other interventional clinical study,
- Female patients who are pregnant or lactating,
- 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 intrauterine devices (IUDs), sexual abstinence or vasectomized partner.
- History of cardiothoracic surgery,
Show all 16Show fewer
- Active smokers, and smokers who have stopped smoking for less than 1 year,
- Patients with left ventricular ejection fraction (LVEF)<30%,
- Concomitant cardiothoracic procedures (i.e. rhythm, aortic, valve surgery, etc.)
- Requires a planned therapeutic, interventional, or surgical procedure within 1 month (30 days) before or after the scheduled index procedure,
- Chronic or acute renal failure requiring renal replacement therapy,
- Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to scheduled index procedure,
- History of bleeding disorders or coagulopathies,
- Contraindicated for internal thoracic artery (ITA) harvesting (i.e. obstruction / aortoiliac occlusive disease / radiation therapy at the thoracic region). For additional radial artery harvesting, a negative Allen test is contraindicated,
- Need for urgent and/or emergent surgery for any reason,
- During the operation, patients can still be excluded from the study in accordance to the instructions of use for the Elana Anastomotic System.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
St. Antonius Ziekenhuis
Nieuwegein, The Netherlands, 3435
Principal Investigator
Bart Van Putte, MD, PhD
About this study
Official title: A Prospective Multicenter Trial to Evaluate the Elana Anastomotic System for Multi-Arterial Coronary Artery Bypass Grafting
The purpose of the trial is to evaluate the feasibility and safety of multiple Elana Anastomotic Systems to anastomose multiple arterial grafts during coronary artery bypass grafting (CABG). In the first trial performed with the Elana Anastomotic System, the SAFE-CAB trial, only a single anastomosis with the left internal mammary artery (LIMA) was created with the system to the left anterior descending (LAD) coronary artery or a large Diagonal side-branch of the LAD. This is the most important bypass for patients, often described as the anastomosis that guarantees the survival of patients.
However, often multiple anastomoses need to be created during bypass surgery. In the previous study, those anastomoses were performed using vein grafts with standard-of-care hand-sewn techniques. A large body of evidence exists indicating that arterial grafts provide better long-term outcomes for patients undergoing CABG procedures, mainly using the right internal mammary artery (RIMA), but also the Radial Artery, for anastomosis to the Circumflex (Cx) artery and sometimes the Right Coronary Artery. With assurance of safety and effectiveness of the Elena Anastomotic System for LIMA-to-LAD anastomoses and the similarity of the LIMA-to-LAD anastomosis to other arterial anastomoses (e.g., RIMA-to-Cx and RA-to-RCA) as a result of similar vessel diameters and anatomical features, the Elana Anastomotic System is considered to be suitable for multi-arterial bypass procedures.
Therefore, this study aims to expand on the evidence of using the Elana Anastomotic System in a more complete multi-arterial CABG operation, where two or three anastomoses will be created with the Elana Anastomotic System in order to present a more comprehensive solution.
- Being tested
- The Elana Anastomotic System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Elana Anastomotic SystemDevice
The Elana Anastomotic System is a medical device and is intended to create a suture less blood vessel anastomosis in Coronary Artery Bypass Grafting (CABG) procedures on the beating heart, without blo
| Study group | Role | What they receive |
|---|---|---|
| Patients will receive two or three bypasses using the Elana Anastomotic System. | Experimental | The Elana Anastomotic System is a medical device and is intended to create a suture less blood vessel anastomosis in Coronary Artery Bypass Grafting (CABG) procedures on the beating heart, without blood flow occlusion. Receives: Device: The Elana Anastomotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint is defined as the proportion of patients free from all Major Adverse Cardiac Events (MACEs)
MACE is a composite safety parameter that includes the following events:
- Cardiac-related mortality,
- Myocardial Infarction (in the vessel anastomosed with the Elana Anastomotic System)
- Repeated clinically-driven target-vessel coronary revascularization (in the vessel anastomosed with the Elana Anastomotic System).
Measured: Collected 1 year (365 days) after the surgery
Secondary outcomes (1)
The secondary effectiveness endpoint is defined as the graft patency for the ELANA graft/anastomosis.
Graft patency for the ELANA graft/anastomosis will be determined for each ELANA anastomosis separately with coronary angiography (CAG) or coronary computed tomography angiography (CCTA), preferably a photon-counting CT (PCCT).
Measured: Performed half an year after the surgery (180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Grafting (CABG) SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AMT Medical BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005843
- Sponsor's protocol ID
- MULTI-CAB
- Other IDs
- NL-009777
- Acronym
- MULTI-CAB
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beukers SHQ, Jacobs S, Klein P, Bronkers G, Moormans LR, Berg JT, Falk V, van Putte BP. The first prospective safety and effectiveness trial of the excimer laser assisted nonocclusive anastomosis system in coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2026 Oct;172(4):1033-1041.e1. doi: 10.1016/j.jtcvs.2026.05.028. Epub 2026 Jun 22.
PubMed 42331280
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Trial to Evaluate the Elana Anastomotic System for Multi-Arterial Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07005843
- Acronym / sponsor ID
- MULTI-CAB / MULTI-CAB
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- AMT Medical BVIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to evaluate the feasibility and safety of multiple Elana Anastomotic Systems to anastomose multiple arterial grafts during coronary artery bypass grafting (CABG). In the first trial performed with the Elana Anastomotic System, the SAFE-CAB trial, only a single anastomosis with the left internal mammary artery (LIMA) was created with the system to the left anterior descending (LAD) coronary artery or a large Diagonal side-branch of the LAD. This is the most important bypass for patients, often described as the anastomosis that guarantees the survival of patients.
However, often multiple anastomoses need to be created during bypass surgery. In the previous study, those anastomoses were performed using vein grafts with standard-of-care hand-sewn techniques. A large body of evidence exists indicating that arterial grafts provide better long-term outcomes for patients undergoing CABG procedures, mainly using the right internal mammary artery (RIMA), but also the Radial Artery, for anastomosis to the Circumflex (Cx) artery and sometimes the Right Coronary Artery. With assurance of safety and effectiveness of the Elena Anastomotic System for LIMA-to-LAD anastomoses and the similarity of the LIMA-to-LAD anastomosis to other arterial anastomoses (e.g., RIMA-to-Cx and RA-to-RCA) as a result of similar vessel diameters and anatomical features, the Elana Anastomotic System is considered to be suitable for multi-arterial bypass procedures.
Therefore, this study aims to expand on the evidence of using the Elana Anastomotic System in a more complete multi-arterial CABG operation, where two or three anastomoses will be created with the Elana Anastomotic System in order to present a more comprehensive solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients will receive two or three bypasses using the Elana Anastomotic System. | Experimental | Device: The Elana Anastomotic SystemThe Elana Anastomotic System is a medical device and is intended to create a suture less blood vessel anastomosis in Coronary Artery Bypass Grafting (CABG) procedures on the beating heart, without blood flow occlusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to provide voluntary written Informed Consent and sign the Informed Consent Form to participate in the study prior to any study-related procedure,
- Is 18 years or older,
- Assigned for CABG by the cardiologist and/or cardiothoracic surgeon with one or more vessel disease requiring multiple distal anastomoses, including one on the left anterior descending coronary artery (LAD),
- 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.
Key exclusion criteria (16 listed)
- Patient is unlikely to cooperate or is legally incompetent, including patients who are institutionalized by court or official order,
- Any condition which could interfere with the patient's ability to comply with the study,
- Ongoing participation in any other interventional clinical study,
- Female patients who are pregnant or lactating,
- 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 intrauterine devices (IUDs), sexual abstinence or vasectomized partner.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Elana Anastomotic SystemThe Elana Anastomotic System is a medical device and is intended to create a suture less blood vessel anastomosis in Coronary Artery Bypass Grafting (CABG) procedures on the beating heart, without blo | Device | Patients will receive two or three bypasses using the Elana Anastomotic System. |
Primary outcome
The primary safety endpoint is defined as the proportion of patients free from all Major Adverse Cardiac Events (MACEs)
Time frame: Collected 1 year (365 days) after the surgery
MACE is a composite safety parameter that includes the following events: * Cardiac-related mortality, * Myocardial Infarction (in the vessel anastomosed with the Elana Anastomotic System) * Repeated clinically-driven target-vessel coronary revascularization (in the vessel anastomosed with the Elana Anastomotic System).
1 secondary outcome
The secondary effectiveness endpoint is defined as the graft patency for the ELANA graft/anastomosis.
Time frame: Performed half an year after the surgery (180 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 42331280Beukers SHQ, Jacobs S, Klein P, Bronkers G, Moormans LR, Berg JT, Falk V, van Putte BP. The first prospective safety and effectiveness trial of the excimer laser assisted nonocclusive anastomosis system in coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2026 Oct;172(4):1033-1041.e1. doi: 10.1016/j.jtcvs.2026.05.028. Epub 2026 Jun 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Elana Anastomotic System in people with Coronary Artery Bypass Grafting (CABG) Surgery, run by AMT Medical BV at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary safety endpoint is defined as the proportion of patients free from all Major Adverse Cardiac Events (MACEs) (time frame: Collected 1 year (365 days) after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07005843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.