Back to resultsXeltis Hemodialysis Access Graft: aXess Pivotal Study
Primary Purpose
End-stage Renal Disease
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Xeltis Hemodialysis Access (aXess) graft
Sponsored by
About this trial
This is an interventional treatment trial for End-stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
- At least 18 years of age at screening
- Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
- The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent
- The patient has been informed and agrees to pre- and post- procedure follow-up
- Life expectancy of at least 12 months
Exclusion Criteria:
- 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
- Uncontrolled or poorly controlled diabetes
- Abnormal blood values that could influence patient recovery and or/ graft hemostasis
- 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
- Any active local or systemic infection
- Known heparin-induced thrombocytopenia
- Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
- Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
- Anticipated renal transplant within 6 months
- Known or suspected central vein obstruction on the side of planned graft implantation
- Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft
- Previous enrolment in this study
- Subject is participating in another study
- Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- 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)
Sites / Locations
- AZ Sint Jan BruggeRecruiting
- ZOL GenkRecruiting
- UZ GhentRecruiting
- Universitätsklinikum Köln
- Athens Medical CenterRecruiting
- University General Hospital of PatrasRecruiting
- Ospedali Riuniti Torrette di Ancona
- Policlinico di Bari
- Policlinico di Sant'Orsola
- Università degli studi di Padova / Azienda ospedaliera di Padova
- Universita degli studi dell'Insubria
- Pauls Stradins Clinical University HospitalRecruiting
- The Lower Silesia Center of Heart Diseases MEDINETRecruiting
- Santa Maria HospitalRecruiting
- Grupo de Estudos VascularesRecruiting
- DaVita Sacavém
- Centro Hospitalar Vila Nova de Gaia / Espinho
- Bellvitge University Hospital
- Hospital Clínic de Barcelona
- Hospital Universitario de la Ribera
- Queen Elizabeth University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
aXess graft
Arm Description
Outcomes
Primary Outcome Measures
Primary patency rate
Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Freedom from device-related SAE during the first 6 months
Secondary Outcome Measures
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.
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).
Time (expressed in months) to first intervention and to access abandonment
Rate of access-related interventions required to achieve/maintain patency
Freedom from device-related SAE
Rate of access site infections
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 to first cannulation
Following first cannulation, number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05473299
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
June 30, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xeltis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aXess graft
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Xeltis Hemodialysis Access (aXess) graft
Intervention Description
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 Measure Information:
Title
Primary patency rate
Description
Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Time Frame
6 months
Title
Freedom from device-related SAE during the first 6 months
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Implantation success rate
Description
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.
Time Frame
1 day, from moment of implant until end of procedure day
Title
Patency (primary, primary assisted, secondary, and functional) rates
Description
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).
Time Frame
6, 12, 18, 24 and 60 months
Title
Time (expressed in months) to first intervention and to access abandonment
Time Frame
60 months
Title
Rate of access-related interventions required to achieve/maintain patency
Time Frame
6, 12, 18, 24, and 60 months
Title
Freedom from device-related SAE
Time Frame
12, 18, 24, and 60 months
Title
Rate of access site infections
Time Frame
6, 12, 18, 24, and 60 months
Title
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
Title
Time to first cannulation
Time Frame
12 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start or maintain hemodialysis therapy
At least 18 years of age at screening
Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess graft
The patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent
The patient has been informed and agrees to pre- and post- procedure follow-up
Life expectancy of at least 12 months
Exclusion Criteria:
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
Uncontrolled or poorly controlled diabetes
Abnormal blood values that could influence patient recovery and or/ graft hemostasis
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
Any active local or systemic infection
Known heparin-induced thrombocytopenia
Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
Anticipated renal transplant within 6 months
Known or suspected central vein obstruction on the side of planned graft implantation
Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally than the previous failed graft
Previous enrolment in this study
Subject is participating in another study
Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliane Schutte
Phone
+31 40 751 7614
Email
clinical@xeltis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Gargiulo, Prof
Organizational Affiliation
Policlinico di Sant'Orsola
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
An de Vriese, Dr
Organizational Affiliation
AZ Sint-Jan AV
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint Jan Brugge
City
Brugge
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan de Letter
Facility Name
ZOL Genk
City
Genk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigi Nauwelaers
Facility Name
UZ Ghent
City
Ghent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annick D'Haeninck
Facility Name
Universitätsklinikum Köln
City
Köln
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Matoussevitch
Facility Name
Athens Medical Center
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panagiotis Theodoridis
Facility Name
University General Hospital of Patras
City
Patras
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stavros Kakkos
Facility Name
Ospedali Riuniti Torrette di Ancona
City
Ancona
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reza Ebrahimi
Facility Name
Policlinico di Bari
City
Bari
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loreto Gesualdo
Facility Name
Policlinico di Sant'Orsola
City
Bologna
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro Gargiulo
Facility Name
Università degli studi di Padova / Azienda ospedaliera di Padova
City
Padova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirko Menegolo
Facility Name
Universita degli studi dell'Insubria
City
Varese
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Tozzi
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danis Krievins
Facility Name
The Lower Silesia Center of Heart Diseases MEDINET
City
Wrocław
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakub Turek
Facility Name
Santa Maria Hospital
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Augusto Ministro
Facility Name
Grupo de Estudos Vasculares
City
Porto
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luís Alvarenga Loureiro
Facility Name
DaVita Sacavém
City
Sacavém
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artur Mendes
Facility Name
Centro Hospitalar Vila Nova de Gaia / Espinho
City
Vila Nova De Gaia
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreia Coelho
Facility Name
Bellvitge University Hospital
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon Vila Coll
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaspar Mestres
Facility Name
Hospital Universitario de la Ribera
City
Valencia
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Palma Fariñas Alija
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kingsmore
12. IPD Sharing Statement
Learn more about this trial
Xeltis Hemodialysis Access Graft: aXess Pivotal Study
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