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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT01173718
Eligibility Criteria:
Inclusion Criteria:\>
1. Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. \>
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2. Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. \> \>\>
3. The patient must be able to have the vascular access graft placed in an upper extremity. \>
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4. The patient is 18 years of age or older. \>
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5. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. \>
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6. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. \> \>\>
7. The patient or his/her legal guardian is willing to provide informed consent. \>
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\>\> Exclusion Criteria:\>
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1. The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.\>
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2. The patient currently has a known or suspected systemic infection.\>
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3. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\>
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4. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. \>
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5. The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.\>
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6. The patient is enrolled in another investigational study.\>
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7. The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\>
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8. Study device is intended to be used temporarily.\>
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9. The patient has had \>2 previous arteriovenous accesses in treatment arm.\>
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10. Patient is taking Aggrenox®.\>
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11. The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.\>
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12. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(\>10 mg), cyclosporine, tacrolimus or cyclophosphamide.\>
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13. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\>
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14. Life expectancy is less than 12 months.\>
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15. The patient is pregnant.\>
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16. The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01173718
Study Brief:
Protocol Section:
NCT01173718