EndoAVFA Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population (STEP Study)

Inclusion Criteria:

1. Male or Female Age of at least 18 years
2. CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart.
3. Provide written informed consent using a form that is approved by the Institutional Review Board (IRB) prior to collection of study data or performance of study procedures.
4. Currently not on hemodialysis.
5. Life expectancy of at least one year
6. Meets Anatomical Criteria for EndoAVF creation via pre-procedure Duplex or Venography Vascular anatomy suitable for creation of the AV fistula
7. Willing to comply with the specified follow-up evaluations

Exclusion Criteria:

1. Anatomical exclusion criteria met
2. Thought to need dialysis within 30 days.
3. The subject is in a hypercoagulable state.
4. The subject has known bleeding diathesis.
5. The subject has insufficient cardiac output to support a native fistula in the opinion of the investigator.
6. Known history of active intravenous drug abuse.
7. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
8. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
9. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).