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

NCT04545112 | Enrolling By Invitation DMC

• 1 other identifier: XEL-CR-07
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Intimal hyperplasia area

  12 months

• Graft patency

  30 days, 6 months, 12 months

• Lumen diameter uniformity

  30 days, 6 months, 12 months

• Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)

  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

  30 days and 6 months

Study Arms (1)

XABG

EXPERIMENTAL

Device: CABG

Interventions

CABG DEVICE

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.

XABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xeltis: lead

Study Sites (4)

UZ Leuven

Leuven, Belgium

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Location

John Paul II Hospital Krakow

Krąków, Poland

Location

Medicover Hospital

Warsaw, Poland

Location

Study Officials

• Bart Meuris, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 10, 2020
• Study Start: October 22, 2020
• Primary Completion: March 15, 2026
• Study Completion (Estimated): February 15, 2031
• Last Updated: September 3, 2025

Record last verified: 2025-02

Locations

LI (1); PL (2); BE (1)