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

• ClinicalTrials.gov Identifier: NCT04545112
• Recruitment Status: Enrolling by invitation
• First Posted: September 10, 2020
• Last Update Posted: January 26, 2023
• Sponsor: Xeltis
• Information provided by (Responsible Party): Xeltis

Tracking Information

• First Submitted Date: August 28, 2020
• First Posted Date: September 10, 2020
• Last Update Posted Date: January 26, 2023
• Actual Study Start Date: October 22, 2020
• Estimated Primary Completion Date: March 15, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 3, 2020)

• Procedural success during the first 30 days [ Time Frame: 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%
• Freedom from device related Serious Adverse Events (SAEs) [ Time Frame: 30 days ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 3, 2020)

• Intimal hyperplasia area [ Time Frame: 12 months ]
  Assessed by OCT
• Graft patency [ Time Frame: 30 days, 6 months, 12 months ]
  Patency defined as a diameter stenosis less than 50%
• Lumen diameter uniformity [ Time Frame: 30 days, 6 months, 12 months ]
  Using Fitzgibbon's 3-point ordinal uniformity scale
• Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: 30 days, 6 months, 12 months, and yearly until 5 years ]
  Absence of device related SAEs
• Freedom from vein harvesting related wound infection, non-infective wound healing disturbances, and leg pain [ Time Frame: 30 days and 6 months ]
  Leg pain will be assessed by standard 10-point VAS scale and presented as descriptive statistics
• Composite of all causes of mortality - (cerebrovascular stroke, myocardial infarction, re-operation, or intervention) [ Time Frame: 5 years ]
  Assessed for XABG and Saphenous vein graft (SVG) separately

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• Brief 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.

Study Arms

Experimental: XABG

Intervention: Device: CABG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: September 3, 2020): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 15, 2026
• Estimated Primary Completion Date: March 15, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Lithuania

Administrative Information

• NCT Number: NCT04545112
• Other Study ID Numbers: XEL-CR-07
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Xeltis
• Original Responsible Party: Same as current
• Current Study Sponsor: Xeltis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bart Meuris, MD; UZ Leuven

• PRS Account: Xeltis
• Verification Date: January 2023