Clinical trial NCT05473299: Xeltis Hemodialysis Access Graft: aXess Pivotal Study
Official title: Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: End-stage Renal Disease
Lead sponsor: Xeltis
Sponsor class: INDUSTRY
First posted: 2022-07-25
Enrollment: 120
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 pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.


Eligibility criteria: Inclusion Criteria:

1. Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
2. At least 18 years of age at screening
3. Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
4. The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent
5. The patient has been informed and agrees to pre- and post- procedure follow-up
6. Life expectancy of at least 12 months

Exclusion Criteria:

1. History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF \<25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
2. Uncontrolled or poorly controlled diabetes
3. Abnormal blood values that could influence patient recovery and or/ graft hemostasis
4. Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds
5. Any active local or systemic infection
6. Known heparin-induced thrombocytopenia
7. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
8. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
9. Anticipated renal transplant within 6 months
10. Known or suspected central vein obstruction on the side of planned graft implantation
11. Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft
12. Previous enrolment in this study
13. Subject is participating in another study
14. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
15. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit

Intra-operative exclusion criteria:

1. Unsuitable anatomy to implant the aXess graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)

Primary outcomes:
measure: Primary patency rate
timeFrame: 6 months
measure: Freedom from device-related SAE during the first 6 months
timeFrame: up to 6 months
Secondary outcomes:
measure: Implantation success rate
timeFrame: 1 day, from moment of implant until end of procedure day
measure: Patency (primary, primary assisted, secondary, and functional) rates
timeFrame: 6, 12, 18, 24 and 60 months
measure: Time (expressed in months) to first intervention and to access abandonment
timeFrame: 60 months
measure: Rate of access-related interventions required to achieve/maintain patency
timeFrame: 6, 12, 18, 24, and 60 months
measure: Freedom from device-related SAE
timeFrame: 12, 18, 24, and 60 months
measure: Rate of access site infections
timeFrame: 6, 12, 18, 24, and 60 months
measure: Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment
timeFrame: 12 months
measure: Time to first cannulation
timeFrame: 12 months
measure: Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
timeFrame: 12 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge
city: Genk
country: Belgium
facility: ZOL Genk
city: Ghent
country: Belgium
facility: UZ Ghent
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Athens
country: Greece
facility: LAIKO General Hospital of Athens
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Ancona
country: Italy
facility: Ospedali Riuniti Torrette di Ancona
city: Bari
country: Italy
facility: Policlinico di Bari
city: Bologna
country: Italy
facility: Policlinico di Sant'Orsola
city: Padova
country: Italy
facility: Università degli studi di Padova / Azienda ospedaliera di Padova
city: Varese
country: Italy
facility: Universita degli studi dell'Insubria
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Poznań
country: Poland
facility: Private hospital MedPolonia Poznan
city: Wrocław
country: Poland
facility: The Lower Silesia Center of Heart Diseases MEDINET
city: Lisboa
country: Portugal
facility: Santa Maria Hospital
city: Porto
country: Portugal
facility: Grupo de Estudos Vasculares
city: Sacavém
country: Portugal
facility: DaVita Sacavém
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Valencia
country: Spain
facility: Hospital Universitario de la Ribera
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham - QE
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: Policlinico di Sant'Orsola
name: Mauro Gargiulo, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Sint-Jan AV
name: An de Vriese, Dr
role: PRINCIPAL_INVESTIGATOR
References: