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:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT00808561
Eligibility Criteria:
Inclusion Criteria:
To participate in this study, the subject MUST have all of the following for inclusion in the study:
* The subject must be \> 18 years of age, male or female
* Subject requires creation of dialysis access secondary to ESRD in the opinion of the referring nephrologist
* Target arm may have a failed radiocephalic fistula
* Contralateral failed or failing access may exist
* The subject must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.
Exclusion Criteria:
To participate in this study, the subject may NOT HAVE any of the following at enrollment to the study:
* Target arm has existing forearm AV graft, either functional or non-functional
* Target arm has existing fistula, either functional or non-functional, other than a radio-cephalic at the wrist
* Target arm has documented subclavian vein occlusion
* Target arm has obviously suitable cephalic vein and radial artery for a primary radiocephalic fistula
* Target arm has no superficial veins existing as options for primary access. If so, a second surgeon will review the ultrasound to confirm
* Active local or systemic infection at the time of surgery
* Known hypercoagulable state (e.g., antithrombin III deficiency, antiphospholipid or anticardiolipin antibodies, Factor IV Leiden, circulating lupus anticoagulant, history of heparin-induced thrombocytopenia, Protein C or S deficiency, prothrombin mutation or a history of recurrent deep venous thrombosis and/or pulmonary embolism)
* Disseminated malignancy or other terminal condition where subject is expected to live less than 6 months.
* Previous randomization in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00808561
Study Brief:
Protocol Section:
NCT00808561