NCT05418816Active, not recruitingNot Applicable
Initial Feasibility Study of SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)
VenoStent1 site in 1 country20 target enrollmentStarted: June 14, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Freedom from Device-Related Safety Events
Study Overview
Brief Summary
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years, male or female;
- •Subjects already receiving hemodialysis treatments that are ultimately referred for a new AVF, per current US KDOQI Clinical Practice Guidelines for Vascular Access updated in 2019 which recommend an AVF or arteriovenous graft (AVG) consistent with patient life-plan, overall goals of care, and anticipated duration of hemodialysis; if life expectancy > 1 year, recommend forearm AVF, forearm AVG, or upper arm AVF; if < 1 year, recommend forearm AVG/upper arm AVG; if urgent start, early cannulation AVG or central venous catheter (CVC);
- •Target cephalic vein inner diameter ≥ 2.5 mm and target artery ≥ 2.0 mm as measured via duplex ultrasound with a tourniquet applied;
- •For radial AVFs, a nonpathological modified Allen test;
- •Triphasic arterial flow and intact venous outflow;
- •A vascular access site being used for hemodialysis that is either positioned contralateral to the planned AVF creation surgery or located in the groin. If the catheter is positioned on the same side as the planned AVF, the catheter will be moved to the other arm prior to the AVF created surgery.
- •Participant is willing and able to comply with study requirements and sign an informed consent.
Exclusion Criteria
- •Planned index procedure to revise or repair an existing fistula;
- •Twelve months or longer with a catheter, on the planned side of AVF creation; or if there has been any previously failed AVF and AVG on the planned side of AVF creation.
- •Significant (> 50%) stenosis at the target vein on the side of surgery, as diagnosed by preoperative ultrasound;
- •Known central venous stenosis > 50%;
- •Amputated limb;
- •Use of a peripherally-inserted central catheter (PICC) line;
- •Abnormal cardiac rhythm;
- •Known coagulation disorder;
- •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 and has not completed the primary endpoint(s), or was previously enrolled in this study;
- •Life expectancy less than 12 months;
- •Patient expecting to undergo kidney transplant surgery within 12 months of enrollment;
- •Patient has a comorbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound data interpretation.
- •Unwillingness or inability to give consent and/or comply with the study follow up schedule.
Outcomes
Primary Outcomes
Freedom from Device-Related Safety Events
Time Frame: Through 6 months post-AVF creation
Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations
Primary Patency
Time Frame: Through 6 months post-AVF creation
Proportion of participants with a created AVF that is not abandoned nor occluded and is free from access thrombosis as well as any intervention required to facilitate, maintain, or reestablish patency (e.g. angioplasty), through 6 months
Cumulative Patency
Time Frame: Through 6 months post-AVF creation
Proportion of participants with a created AVF that is not abandoned or occluded, through 6 months
Secondary Outcomes
- Cumulative Patency(Through 1, 2, 3, 12, 18, and 24 months post-AVF creation)
- Freedom from Device-Related Safety Events(Through 1, 2, 3, 12, 18, and 24 months post-AVF creation)
- Unassisted Physiological Maturation(1, 2, 3, and 6 months post-AVF creation)
- Primary Patency(Through 1, 2, 3, 12, 18, and 24 months post-AVF creation)
- Number of Interventions(Through 1, 2, 3, 6, 12, 18, and 24 months post-AVF creation)
Investigators
Study Sites (1)
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