A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population (STEP St… (NCT04633304) | Clinical Trial Compass
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A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population (STEP Study)
United States30 participantsStarted 2020-12-15
Plain-language summary
This is an investigator-initiated post-marketing study that will evaluate use of the WaveLinQ system, a new and novel method of fistula creation using a percutaneous method in patients who require the creation of an arteriovenous fistula (AVF).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or Female Age of at least 18 years
✓. CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart.
✓. 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.
✓. Currently not on hemodialysis.
✓. Life expectancy of at least one year
✓. Meets Anatomical Criteria for EndoAVF creation via pre-procedure Duplex or Venography Vascular anatomy suitable for creation of the AV fistula
✓. Willing to comply with the specified follow-up evaluations
Exclusion criteria
✕. Anatomical exclusion criteria met
✕. Thought to need dialysis within 30 days.
✕. The subject is in a hypercoagulable state.
✕. The subject has known bleeding diathesis.
✕. The subject has insufficient cardiac output to support a native fistula in the opinion of the investigator.
✕. Known history of active intravenous drug abuse.
What they're measuring
1
Procedure Success
Timeframe: Interval of time from access placement until any intervention is undertaken to maintain or re-establish patency - 6 weeks