SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Purpose
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.
Conditions
- Chronic Kidney Diseases
- End Stage Renal Disease
- Arteriovenous Fistula
- Hemodialysis Access Failure
- ESRD
- Vascular Access Complication
- Renal Failure
- Catheter Complications
- Catheter Dysfunction
- Renal Insufficiency
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Arm |
Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery |
|
|
Sham Comparator Control Arm |
AVF creation surgery without any intervention (untreated AVF control, or standard of care) |
|
Recruiting Locations
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
More Details
- Status
- Recruiting
- Sponsor
- VenoStent
Detailed Description
This is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded clinical trial for CKD patients referred for creation of a new arteriovenous fistula (AVF). This study will involve approximately 200 participants from up to 25 investigational sites, randomized 1:1 to treatment with the SelfWrap or the untreated AVF control (i.e. standard of care, SOC). Participants will be followed for a duration of 36 months.