NCT04545112

Xeltis Coronary Artery Bypass Graft (XABG) First in Human (FIH)

Prospective, Non-randomized, First in Human (FIH) Clinical Study to Assess the Feasibility of the Novel Xeltis Coronary Artery Bypass Graft (XABG)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xeltis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary safety and performance of the XABG technology in patients with multi-vessel atherosclerotic coronary artery disease, scheduled by the local Heart Team to undergo elective coronary artery bypass (CABG) surgery.

Conditions

• Multi Vessel Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CABG	Elective, coronary artery bypass (CABG) surgery. Each study subject will receive an left internal mammary artery (LIMA) conduit to the left anterior descending (LAD) coronary artery. Patients with uncompromised saphenous veins will receive a SVG to the LCX or RCA and the XABG to the remaining territory. Patients with compromised arterial and/or saphenous veins, (i.e., "no-vein" patients), will receive one XABG to the LCX or RCA to achieve incomplete revascularization.

Timeline

• Start date: 2020-10-22
• Primary completion: 2026-03-15
• Completion: 2031-02-15
• First posted: 2020-09-10
• Last updated: 2025-09-03

Locations

4 sites across 3 countries: Belgium, Lithuania, Poland