No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
VenoStent · Industry
Who this trial is looking for
This trial is looking for adults with chronic kidney disease who need a new arteriovenous fistula for dialysis. Participants will receive a special wrap during the procedure and will follow up with the study team for 36 months.
Are You a Good Fit for This Trial?
Rules you outCongestive heart failure NYHA class 4
You may be able to join if
I am at least 18 years old.
I have been referred for a new arteriovenous fistula.
I can follow study requirements and attend follow-up visits.
You may not be able to join if
I am having surgery to fix an existing fistula.
The target artery is less than 2.0 mm in diameter.
The target vein is less than 2.0 mm in diameter.
I have significant narrowing in the target vein.
I have central venous stenosis of at least 50%.
I have a stent in the access circuit.
I have an active infection at the time of surgery.
I have a life expectancy of less than 12 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* Age of at least 18 years
* Referred for creation of a new AVF
* Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months
Exclusion Criteria:
* Planned index procedure to revise or repair an ex…
Inclusion Criteria:
* Age of at least 18 years
* Referred for creation of a new AVF
* Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months
Exclusion Criteria:
* Planned index procedure to revise or repair an existing fistula
* Target artery inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
* Target vein inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
* Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound
* Known central venous stenosis of at least 50% on the side of surgery
* Presence of a stent or a stent graft within the access circuit
* Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation
* Known or suspected active infection at the time of surgery
* Congestive heart failure NYHA class 4
* Prior steal on the side of surgery;
* Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study
* Life expectancy less than 12 months
* Expected to undergo kidney transplant surgery within 6 months of enrollment
* Expected to undergo home hemodialysis
* Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening
* Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study
* Unwillingness or inability to give consent and/or comply with the study follow up schedule
* Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.
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