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Xeltis Coronary Artery Bypass Graft (XABG) First in Human (FIH) | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

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)

NCT04545112•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All gender, 18 years of age or older with a minimum life expectancy of 2 years.
•Elective multi-vessel atherosclerotic CAD patients, selected and accepted by the local Heart Team and confirmed by the Screening Committee for CABG surgery.
•LIMA bypass graft to LAD coronary artery indicated and feasible.
•XABG target vessel(s) with proximal occlusion and/or critical stenosis. and with a diameter of ≥ 2 mm and sufficient distal run-off (thrombolysis in myocardial infarction risk (TIMI)-Score ≥ 2).
•Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
•Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up CT scan and coronary angiogram.
•Patient is suitable for percutaneous coronary intervention (PCI) procedures in case of required emergent procedures at discretion of the local Heart Team.

Exclusion Criteria

•Total arterial bypass grafting indicated and feasible
•Any previous open-heart surgery or surgical/transcatheter procedure that could compromise imaging follow up.
•History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation
•Concomitant cardiac surgery (e.g. valve treatment, ablation).
•Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days prior to the CABG procedure
•Left ventricular ejection fraction ≤ 35%.
•Severe kidney disease, renal dysfunction (Cr\> 2.0mg/dL) or Glomerular Filtration Rate (GFR) \< 50mL/min or active dialysis patients.
•Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) \<1.5 lit/sec.
•Endocarditis, pericarditis or any other active systemic infection that would interfere with subject safety.
•Active bleeding disorder and/or any coagulopathy or thromboembolic disease or other indication requiring anticoagulation
+14 more criteria

Locations (4)

UZ Leuven

Leuven, Belgium

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

John Paul II Hospital Krakow

Krąków, Poland

Medicover Hospital

Warsaw, Poland

Key Dates

Start Date

October 22, 2020

Primary Completion Date

March 15, 2026

Completion Date

February 15, 2031

Last Updated

September 3, 2025

Enrollment

ESTIMATED participants

Conditions

Multi Vessel Coronary Artery Disease

Interventions

CABG

DEVICE

Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease

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COMPLETEDNA

The TransCatheter Valve and Vessels Trial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease

The TransCatheter Valve and Vessels Trial

FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction