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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multi Vessel Coronary Artery Disease
• Intervention / Treatment: Device: CABG

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Leuven
• Lithuania
  • Vilnius, Lithuania
    • Vilnius University Hospital Santaros Klinikos
• Poland
  • Krąków, Poland
    • John Paul II Hospital Krakow
  • Warsaw, Poland
    • Medicover Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Known Heparin Induced Thrombocytopenia (HIT)
• Abnormal blood values (e.g. leukopenia, anemia or thrombocytopenia) that could influence graft hemostasis or patient recovery.
• Use of immunosuppressive therapy or medication or active clinically inflammatory/autoimmune disease or immunodeficiency that likely interferes with restorative therapies
• Known and non-treatable allergies to study device (Nitinol) or agents/medication, such as contrast agents, antiplatelet therapy, beta-blocker, statins required for study assessment or optimal post-CABG medical treatment (hospital SOC).
• Need for emergency surgery for any reason and/or intervention/surgery prior to and within 12 months after the CABG surgery that requires antiplatelet therapy discontinuation.
• Currently in investigational device or drug study or participated in the last 30 days.
• Pregnancy or females currently lactating or childbearing potential who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years.
• Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
• Has any other condition, in the opinion of the principal investigator, which would put the patient at increased risk from participating in the study or otherwise prevent participation.

Intra-operative Exclusion Criteria:

• Severe calcified aorta (porcelain aorta) or diseased aorta that precludes proximal vein graft anastomoses
• Unsuccessful LIMA to LAD anastomosis
• After chest opening and visual inspection identification of active pericarditis/endocarditis and/or diffuse calcification in target vessels and/or any other reason precluding sufficient distal anastomoses.
• Smaller distal coronary artery and/or poor distal run-off and/or XABG patient/device size mismatch as initially expected in the pre-operative workup.
• Hemodynamic instability before XABG attempt

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: XABG

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success during the first 30 days	XABG technology performs as intended with successful proximal and distal anastomoses and graft patency at the conclusion of the procedure and at 30 days. Patency is defined as a diameter stenosis less than 50%	30 days
Freedom from device related Serious Adverse Events (SAEs)		30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intimal hyperplasia area	Assessed by OCT	12 months
Graft patency	Patency defined as a diameter stenosis less than 50%	30 days, 6 months, 12 months
Lumen diameter uniformity	Using Fitzgibbon's 3-point ordinal uniformity scale	30 days, 6 months, 12 months
Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)	Absence of device related SAEs	30 days, 6 months, 12 months, and yearly until 5 years
Freedom from vein harvesting related wound infection, non-infective wound healing disturbances, and leg pain	Leg pain will be assessed by standard 10-point VAS scale and presented as descriptive statistics	30 days and 6 months

Collaborators and Investigators

• Sponsor: Xeltis
• Investigators: Principal Investigator: Bart Meuris, MD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): February 15, 2031

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: XEL-CR-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No