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ENROLLING BY INVITATION
NCT04545112
NA

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

Sponsor: Xeltis

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2020-10-22

Completion Date

2031-02-15

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

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.

Locations (4)

UZ Leuven

Leuven, Belgium

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

John Paul II Hospital Krakow

Krąków, Poland

Medicover Hospital

Warsaw, Poland