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

Multi Vessel Coronary Artery Disease Clinical Trial

— XABG-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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04545112
• Other study ID #: XEL-CR-07
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: March 15, 2026

Study information

• Verified date: January 2023
• Source: Xeltis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A FIH study to collect preliminary device safety, feasibility and performance data of the XABG in patients with symptomatic coronary artery disease (SCAD), with suitable multi vessel disease (MVD) and selected by the local Heart Team for elective coronary artery bypass grafts surgery of at least 3 bypass grafts (minimally 1 artery and 2 veins or 2 arteries and 1 vein).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All gender, 19 years of age or older with a minimum life expectancy of 2 years
• Elective patient, selected and accepted by the local Heart Team and confirmed by the Screening Committee for an on-pump full sternotomy CABG surgery
• IMA conduit indicated and feasible for the LAD, SVG CABG indicated and feasible for the circumflex artery (LCX) and right coronary artery (RCA) territories
• Native coronary vessels with proximal occlusion and/or critical stenosis. XABG target vessel 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/MRI 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:

• Any previous open-heart surgery or surgical/transcatheter procedure resulting in complex CABG surgery and/or suboptimal cardiovascular imaging of the chest
• History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation
• Concomitant cardiac surgery (e.g. valve treatment, ablation)
• No or insufficient intrathoracic arteries and/or saphenous veins available to undergo full CABG procedure (i.e. treat all target vessels)
• 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.
• Condition requiring immunosuppressive therapy or any chronic inflammatory/autoimmune disease or medication that likely interferes with restorative therapies
• 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 of 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
• No or insufficient intrathoracic artery and/or saphenous veins available to undergo full CABG procedure (i.e. treat all target vessels).
• Unsuccessful IMA 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 XABG and/or SVG anastomoses.
• Smaller distal coronary artery and/or poor distal run-off as initially expected based on the coronary angiogram.
• Hemodynamic instability before XABG attempt

Related Conditions & MeSH terms

• Coronary Artery Disease
• Multi Vessel Coronary Artery Disease

Intervention

Device:
• CABG
Elective, on-pump coronary artery bypass (CABG) surgery. Each study subject will receive an internal mammary artery (IMA) conduit to the left anterior descending (LAD) coronary artery, one saphenous vein graft and one XABG medical device.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Xeltis

Countries where clinical trial is conducted

Belgium,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Freedom from device related Serious Adverse Events (SAEs)		30 days
Secondary	Intimal hyperplasia area	Assessed by OCT	12 months
Secondary	Graft patency	Patency defined as a diameter stenosis less than 50%	30 days, 6 months, 12 months
Secondary	Lumen diameter uniformity	Using Fitzgibbon's 3-point ordinal uniformity scale	30 days, 6 months, 12 months
Secondary	Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)	Absence of device related SAEs	30 days, 6 months, 12 months, and yearly until 5 years
Secondary	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	30 days and 6 months
Secondary	Composite of all causes of mortality - (cerebrovascular stroke, myocardial infarction, re-operation, or intervention)	Assessed for XABG and Saphenous vein graft (SVG) separately	5 years