Tests a new bypass graft device during heart bypass surgery

Trial details

Who runs it

Xeltis

Trial code

NCT04545112

Record updated

29 July 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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: Any previous open-heart surgery or surgical/transcatheter procedure that could compromise imaging follow up; 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; 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; History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation; 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; 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); 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:; 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; Total arterial bypass grafting indicated and feasible; Known Heparin Induced Thrombocytopenia (HIT); Abnormal blood values (e.g. leukopenia, anemia or thrombocytopenia) that could influence graft hemostasis or patient recovery; 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; 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.

ClinicalTrials.gov NCT04545112