Xeltis Hemodialysis Access Graft: aXess Pivotal Study

End-stage Renal Disease Clinical Trial

Official title:

Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473299
• Other study ID #: XEL-CR-10
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: June 30, 2029

Study information

• Verified date: June 2023
• Source: Xeltis
• Contact: Eliane Schutte
• Phone: +31 40 751 7614
• Email: clinical[@]xeltis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 30, 2029
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Xeltis Hemodialysis Access (aXess) graft
The aXess graft is a sterile, regenerative biodegradable polymer-based vascular graft, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess graft is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

Locations

Country	Name	City	State
Belgium	AZ Sint Jan Brugge	Brugge
Belgium	ZOL Genk	Genk
Belgium	UZ Ghent	Ghent
Germany	Universitätsklinikum Köln	Köln
Greece	Athens Medical Center	Athens
Greece	University General Hospital of Patras	Patras
Italy	Ospedali Riuniti Torrette di Ancona	Ancona
Italy	Policlinico di Bari	Bari
Italy	Policlinico di Sant'Orsola	Bologna
Italy	Università degli studi di Padova / Azienda ospedaliera di Padova	Padova
Italy	Universita degli studi dell'Insubria	Varese
Latvia	Pauls Stradins Clinical University Hospital	Riga
Poland	The Lower Silesia Center of Heart Diseases MEDINET	Wroclaw
Portugal	Santa Maria Hospital	Lisboa
Portugal	Grupo de Estudos Vasculares	Porto
Portugal	DaVita Sacavém	Sacavém
Portugal	Centro Hospitalar Vila Nova de Gaia / Espinho	Vila Nova De Gaia
Spain	Bellvitge University Hospital	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Universitario de la Ribera	Valencia
United Kingdom	Queen Elizabeth University Hospital	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Xeltis

Countries where clinical trial is conducted

Belgium,  Germany,  Greece,  Italy,  Latvia,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency rate	Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.	6 months
Primary	Freedom from device-related SAE during the first 6 months		up to 6 months
Secondary	Implantation success rate	Defined as a technically successful aXess graft implantation in the planned configuration, free from kinking and tension in the anastomoses. This is assessed at the procedure day itself.	1 day, from moment of implant until end of procedure day
Secondary	Patency (primary, primary assisted, secondary, and functional) rates	Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.; Assisted primary patency: Defined as the interval between vascular access creation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the vascular access.; Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up).; Functional patency: Defined as the interval between first cannulation and abandonment, including occurrence of a censored event (death, change of modality, loss of follow-up).	6, 12, 18, 24 and 60 months
Secondary	Time (expressed in months) to first intervention and to access abandonment		60 months
Secondary	Rate of access-related interventions required to achieve/maintain patency		6, 12, 18, 24, and 60 months
Secondary	Freedom from device-related SAE		12, 18, 24, and 60 months
Secondary	Rate of access site infections		6, 12, 18, 24, and 60 months
Secondary	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		12 months
Secondary	Time to first cannulation		12 months
Secondary	Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment		12 months