Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT04146012
Eligibility Criteria:
Inclusion Criteria:
Patients are eligible to be included in the study only if they meet the following criteria:
1. Male or Female, 18 years or older
2. Diagnosis of End Stage Renal Disease (ESRD) and require vascular access for hemodialysis
3. Native \[autogenous tissue\] AV fistula creation or access is not indicated or non-viable \[disadvantaged veins\]
4. Requiring repair of an existing fistula or conduit, but only if using Artegraft as an interposition placement and the Artegraft is cannulated \[not the fistula\]. Artegraft must be place in a fresh subcutaneous tunnel. Thigh loop grafts will not be used.
5. Able to accommodate vascular graft placement in the upper extremity (i.e., forearm, or upper arm)
6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)
7. Able and willing to comply with the study protocol
8. Agrees to initiate and maintain hemodialysis treatments
9. Life expectancy is \> 1 year based on physician assessment
Exclusion Criteria:
Patients are excluded from the trial if any of the following criteria apply:
1. High grade central venous stenosis/occlusion
2. Breast-feeding, pregnant or planning pregnancy within next 12 months.
3. Non-resolved infected existing grafts
4. Documented sepsis/bacteremia by blood culture within 4 weeks of implantation.
5. History of non-controlled immunodeficiency syndrome, including AIDS/HIV; Active clinically significant immune-mediated disease, not controlled by low-dose maintenance immunosuppression. The diagnosis of HIV alone, provided adequately treated, is not a contraindication for enrolment.
6. Severe liver dysfunction and/or coagulation or bleeding disorders.
7. Elevated platelet count \> 1 million cells/mm3
8. History of heparin-induced thrombocytopenia syndrome (HIT)
9. Documented hypercoagulable state
10. Currently participating in another investigational drug or device study which may clinically interfere with any endpoints of this trial
11. Known hypersensitivity or contraindication to device materials or procedural medications that cannot be adequately managed medically
12. History or evidence of severe cardiac disease (NYHA Functional Class III or IV), , myocardial infarction within 6 months of enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina, uncontrolled CHF
13. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e. arterial inflow insufficient to support hemodialysis)
14. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin
15. Bleeding diathesis, other than that associated with ESRD
16. Scheduled renal transplant within 6 months
17. Patients who require chronic anticoagulation except for antiplatelet therapy. Patients currently receiving or who have received within the last month direct thrombin inhibitors, factor Xa inhibitors, or vitamin K antagonists should not be included in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04146012
Study Brief:
Protocol Section:
NCT04146012