Kidney Disease, End-Stage study: EndoAVF Creation
Official title Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
ClinicalTrials.gov ID: NCT04634916
What this study is testing
- What it's testing
- The study aims to monitor the safety and performance of the WavelinQ system after it has been approved for use.
- Who it's for
- People with end-stage kidney disease who need dialysis and are getting a new blood vessel connection.
- What's involved
- Participants will have a procedure to create an arteriovenous fistula (a connection between an artery and vein) using the WavelinQ device.
- Time commitment
- The study involves follow-up visits to check on the health of the new blood vessel connection over time.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must be either male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient to allow for completion of all study...
- Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- Subject must be willing to comply with the protocol requirements, including clinical follow-up.
- people who have established, non-reversible kidney failure, who are currently on dialysis at screening or are in immediate need (within 6 months of...
- Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography.
You likely can't join if
- 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.
- "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
- The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
See the full eligibility criteria
- Subject must be either male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
- Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- Subject must be willing to comply with the protocol requirements, including clinical follow-up.
- people who have established, non-reversible kidney failure, who are currently on dialysis at screening or are in immediate need (within 6 months of endoAVF creation) of dialysis.
- Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography.
- Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram.
- Subject has adequate collateral circulation to the hand, in the opinion of the Investigator.
- At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein.
- 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.
- "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure.
- 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).
- The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy...
- The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints.
- The subject has central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned endoAVF creation.
- Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography.
- Occlusion or stenosis \> 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography.
- Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography.
- Presence of significant calcification at the target endoAVF location that could potentially impact the how well it works of endoAVF creation as determined by the Investigator.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Lakeland, Florida, United States
- Springfield, Massachusetts, United States
- West Springfield, Massachusetts, United States
- Worcester, Massachusetts, United States
- Albany, New York, United States
- Toledo, Ohio, United States
- Butler, Pennsylvania, United States
- Chattanooga, Tennessee, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Bedford Park, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; San Francisco, California, United States; Jacksonville, Florida, United States; Lakeland, Florida, United States; Springfield, Massachusetts, United States; West Springfield, Massachusetts, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.