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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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CKD Stage 3, CKD Stage 4, CKD Stage 5

Intervention / Treatment
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* Device: EndoAVF System for endovascular AV fistula creation


Participation Criteria
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Eligibility Criteria
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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. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated. 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: primary end point
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AVF<br>Single arm study using primary and secondary end points as comperators between subjects. | Device: EndoAVF System for endovascular AV fistula creation<br>* AV fistula creation<br>* Other names: WavelinQ™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | 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 | Percent of patients who did not require any intervention to be undertaken to maintain or re-establish patency | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD