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

Description

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).

Conditions

CKD Stage 3, CKD Stage 4, CKD Stage 5

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Study Overview

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Study Details

Study overview

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).

A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population

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

Condition
CKD Stage 3
Intervention / Treatment

-

Contacts and Locations

Escondido

California Institute of Renal Research, Escondido, California, United States, 92027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

California Institute of Renal Research,

Osman Khawar, MD, PRINCIPAL_INVESTIGATOR, California Institute of Renal Research

Study Record Dates

2023-12-31