Clinical trial NCT04545112: Xeltis Coronary Artery Bypass Graft (XABG) First in Human (FIH)
Official title: Prospective, Non-randomized, First in Human (FIH) Clinical Study to Assess the Feasibility of the Novel Xeltis Coronary Artery Bypass Graft (XABG)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Multi Vessel Coronary Artery Disease
Lead sponsor: Xeltis
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Procedural success during the first 30 days
timeFrame: 30 days
measure: Freedom from device related Serious Adverse Events (SAEs)
timeFrame: 30 days
Secondary outcomes:
measure: Intimal hyperplasia area
timeFrame: 12 months
measure: Graft patency
timeFrame: 30 days, 6 months, 12 months
measure: Lumen diameter uniformity
timeFrame: 30 days, 6 months, 12 months
measure: Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 30 days, 6 months, 12 months, and yearly until 5 years
measure: Freedom from vein harvesting related wound infection, non-infective wound healing disturbances, and leg pain
timeFrame: 30 days and 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Warsaw
country: Poland
facility: Medicover Hospital
Study officials:
affiliation: UZ Leuven
name: Bart Meuris, MD
role: PRINCIPAL_INVESTIGATOR
References: