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First human trial of artificial bypass graft begins

NCT ID NCT04545112

Disease control Sponsor: Xeltis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This early study tests a new synthetic blood vessel (XABG) for coronary artery bypass surgery in 20 people with multi-vessel heart disease. The graft is designed to work like a natural artery. Researchers are checking if it stays open and is safe in the first 30 days. This is a first step to see if the idea is feasible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
synthetic coronary artery bypass graft (XABG)
What this could lead to
If successful, this could provide a new option for bypass surgery, especially for patients who lack healthy veins for grafting.
What could go wrong
This is a very early, small study with only 20 participants. The graft may not stay open or could cause complications. Much more testing is needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • John Paul II Hospital Krakow

    Krąków, Poland

  • Medicover Hospital

    Warsaw, Poland

  • UZ Leuven

    Leuven, Belgium

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, Lithuania

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Other studies related to the condition(s) this trial covers.