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New treatment option for Chronic Kidney Diseases
Official title SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
ClinicalTrials.gov ID: NCT06001827
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
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
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bullhead City, Arizona, United States
- Marana, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Garden Grove, California, United States
- Tallahassee, Florida, United States
- Fort Wayne, Indiana, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- Lake Success, New York, United States
- Charlotte, North Carolina, United States
- Raleigh, North Carolina, United States
- Charleston, South Carolina, United States
- Columbia, South Carolina, United States
- Florence, South Carolina, United States
- Greenville, South Carolina, United States
- Orangeburg, South Carolina, United States
+ 7 more site(s).
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 - 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?
Study sites include Bullhead City, Arizona, United States; Marana, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Garden Grove, California, United States; Tallahassee, Florida, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.