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Multi Vessel Coronary Artery DiseaseXABG FIHNCT04545112

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

A study testing CABG in people with Multi Vessel Coronary Artery Disease, run by Xeltis at 4 sites in 3 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multi Vessel Coronary Artery Disease
What is being tested?
CABG
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesin 3 countries
Study dates
22 Oct 2020to Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%.
Show all 25Show fewer
  • 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

Trial locations and contacts

4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

4 sites in 3 countries

Poland2 sites

  • John Paul II Hospital Krakow

    Krąków

  • Medicover Hospital

    Warsaw

Other trials in Poland

Belgium1 site

  • UZ Leuven

    Leuven

Other trials in Belgium

Lithuania1 site

  • Vilnius University Hospital Santaros Klinikos

    Vilnius

Other trials in Lithuania

About this study

Official title: 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.

Being tested
CABG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CABGDevice

    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.

Study groups in NCT04545112
Study groupRoleWhat they receive
XABGExperimentalNot described
Receives: Device: CABG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    Measured: 30 days

  2. Freedom from device related Serious Adverse Events (SAEs)

    Measured: 30 days

Secondary outcomes (5)

  1. Intimal hyperplasia area

    Assessed by OCT

    Measured: 12 months

  2. Graft patency

    Patency defined as a diameter stenosis less than 50%

    Measured: 30 days, 6 months, 12 months

  3. Lumen diameter uniformity

    Using Fitzgibbon's 3-point ordinal uniformity scale

    Measured: 30 days, 6 months, 12 months

  4. Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    Absence of device related SAEs

    Measured: 30 days, 6 months, 12 months, and yearly until 5 years

  5. 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

    Measured: 30 days and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start22 Oct 2020
  3. Primary completionFeb 2027 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04545112
Sponsor's protocol ID
XEL-CR-07
Acronym
XABG FIH
Status last verified
Jul 2026
First submitted
28 Aug 2020
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CABG in people with Multi Vessel Coronary Artery Disease, run by Xeltis at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland, Belgium, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural success during the first 30 days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04545112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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