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

February 7, 2023 updated by: California Institute of Renal Research

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This investigator-initiated post-marketing study will evaluate use of the WaveLinQ system, a new and novel method of fistula creation, which uses a percutaneous method to create an AVF. Thirty male and female subjects with CKD 3-5 and who are clinical indicated for arteriovenous fistula (AVF) creation will be enrolled using the WaveLinQ device. Eligibility confirmation will be confirmed during screening up to 28 days from the index procedure. Subjects who are eligible will undergo fistula creation per standard institutional technique (index/baseline) and be followed at least monthly for 6 months per their standard of care plan. Primary, clinical and functional patency will be observed throughout the trial in addition to other data collection points per protocol. The expected total duration of subject participation from screening until the end of study is up to 7 months.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: AVF
Single arm study using primary and secondary end points as comperators between subjects.
Device: EndoAVF System for endovascular AV fistula creation
AV fistula creation
Other Names:
  • WavelinQ™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Success
Time Frame: Interval of time from access placement until any intervention is undertaken to maintain or re-establish patency - 6 weeks
Successful endoAVF creation confirmed by intraprocedural angiography or duplex Ultrasound post procedure
Interval of time from access placement until any intervention is undertaken to maintain or re-establish patency - 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiologically mature endoAVF at 6 months
Time Frame: 6 months
Percent of patients who did not require any intervention to be undertaken to maintain or re-establish patency
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Institute of Renal Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2020

Primary Completion (ANTICIPATED)

December 15, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (ACTUAL)

November 18, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on CKD Stage 4

Clinical Trials on EndoAVF System for endovascular AV fistula creation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe