NCT07005843

A Study Testing the Elana Device for Multi-Artery Heart Bypass Surgery

A Prospective Multicenter Trial to Evaluate the Elana Anastomotic System for Multi-Arterial Coronary Artery Bypass Grafting

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: AMT Medical BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Coronary Artery Bypass Grafting (CABG) Surgery

Interventions

Type	Name	Description
DEVICE	The Elana Anastomotic System	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

Timeline

• Start date: 2025-09-30
• Primary completion: 2028-09-30
• Completion: 2028-12-30
• First posted: 2025-06-05
• Last updated: 2025-06-05

Locations

1 site across 1 country: Netherlands