The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation (NCT04626427) | Clinical Trial Compass
TerminatedNot Applicable
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
Stopped: Due to shifting post-pandemic clinical landscape, concurrent study (NCT04634916) to provide results on analogous endpoints in advance of current projections
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in patients who require a vascular access for hemodialysis (HD).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be able to comprehend, voluntarily sign and date the informed consent form (ICF) prior to collection of clinical investigation data or performance of clinical investigation procedures (or where allowable the participant's legally authorized representative (LAR) on behalf of the participant).
. Be able to and willing to comply with the CIP requirements, including clinical follow-up.
. Be male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient (≥ 24 months) to allow for completion of all clinical investigation procedures.
. Have established, non-reversible kidney failure, who are currently on HD at screening or are in need of a vascular access for HD as determined by the referring clinician.
. Target treatment vein diameter(s) for AVF creation ≥ 2.0 mm as measured via DUS or angiography.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety: Device and Procedure Related Serious Adverse Events (SAEs) - Presented as the Number of Participants With Freedom From Clinical Events Committee (CEC) Adjudicated Device and/or Procedure-Related SAEs.
Timeframe: 30 days
2
Effectiveness: Number of Interventions Per Patient Years to Facilitate and / or Maintain AVF Use
. A target treatment artery diameter ≥ 2.0 mm as measured via DUS or angiography.
. Adequate collateral circulation to the hand, in the opinion of the Principal Investigator (PI) (or authorized designee).
. At least one superficial outflow vein diameter ≥ 2.5 mm as measured via DUS or angiography that is in communication with the target creation site via a proximal forearm perforating vein.
Exclusion criteria
. Active or nontreated hypercoagulable state.
. Known bleeding diathesis.
. Insufficient cardiac output to support the maturation and use of an AVF in the opinion of the PI (or authorized designee).
. Known history of or current active intravenous drug abuse.
. A "planned" major surgical procedure within 6 months following index procedure or major surgery, in the opinion of the PI (or authorized designee), within 30 days prior to index procedure.
. Known allergy or hypersensitivity to contrast media which cannot be adequately treated with pre-medication.
. Known adverse effects to sedation and / or anesthesia which cannot be adequately treated with pre-medication.
. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and / or White Blood Cell (WBC) Count of ≥ 12,000 cells / μL, if collected).