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Trial record 3 of 8 for:    xeltis

Xeltis Hemodialysis Access Graft: aXess Pivotal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05473299
Recruitment Status : Not yet recruiting
First Posted : July 25, 2022
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Xeltis

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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Device: Xeltis Hemodialysis Access (aXess) graft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study
Estimated Study Start Date : October 31, 2022
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : June 30, 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aXess graft 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.




Primary Outcome Measures :
  1. Primary patency rate [ Time Frame: 6 months ]
    Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.

  2. Freedom from device-related SAE during the first 6 months [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Implantation success rate [ Time Frame: 1 day, from moment of implant until end of procedure day ]
    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.

  2. Patency (primary, primary assisted, secondary, and functional) rates [ Time Frame: 6, 12, 18, 24 and 60 months ]

    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).


  3. Time (expressed in months) to first intervention and to access abandonment [ Time Frame: 60 months ]
  4. Rate of access-related interventions required to achieve/maintain patency [ Time Frame: 6, 12, 18, 24, and 60 months ]
  5. Freedom from device-related SAE [ Time Frame: 12, 18, 24, and 60 months ]
  6. Rate of access site infections [ Time Frame: 6, 12, 18, 24, and 60 months ]
  7. 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 [ Time Frame: 12 months ]
  8. Time to first cannulation [ Time Frame: 12 months ]
  9. Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05473299


Contacts
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Contact: Eliane Schutte +31 40 751 7614 clinical@xeltis.com

Sponsors and Collaborators
Xeltis
Investigators
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Principal Investigator: Mauro Gargiulo, Prof Policlinico di Sant'Orsola
Principal Investigator: An de Vriese, Dr AZ Sint-Jan AV
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Responsible Party: Xeltis
ClinicalTrials.gov Identifier: NCT05473299    
Other Study ID Numbers: XEL-CR-10
First Posted: July 25, 2022    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency