SelfWrap-Assisted Arteriovenous Fistulas for Chronic Kidney Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap, in patients with chronic kidney disease who are undergoing the creation of a new arteriovenous fistula (AVF). It is a multi-center, prospective, randomized, double-arm, single-blind study involving approximately 200 participants across 25 investigational sites. Participants will be randomly assigned to receive either the SelfWrap treatment or standard of care, with follow-up assessments conducted over a period of 36 months.

Why it matters

Who can join: the full rules

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.

Where it's running

• AKDHC Bullhead City
  Bullhead City, Arizona, United States Recruiting
• AKDHC Marana Surgery Center
  Marana, Arizona, United States Recruiting
• Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
  Phoenix, Arizona, United States Recruiting
• Banner University Medical Center
  Tucson, Arizona, United States Recruiting
• Orange County Vascular Access Center
  Garden Grove, California, United States Recruiting
• Tallahassee Research Institute
  Tallahassee, Florida, United States Recruiting

Study contacts

• Study coordinator: Mark Barakat, MD
• Email: mark.barakat@venostent.com
• Phone: (832) 429-5362

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.