SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)

Initial Feasibility Study of SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)

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 Overview

• Status: Active, not recruiting
• Conditions: Vascular Diseases; Urologic Diseases; Chronic Kidney Diseases; Renal Insufficiency; Renal Failure; End Stage Renal Disease; Hemodialysis Access Failure; Fistula; Arteriovenous Malformations; Vascular Malformations; End Stage Kidney Disease; Arteriovenous Fistula; Renal Failure Chronic; Vascular Fistula; Catheter Complications; Chronic Kidney Failure; Catheter Dysfunction
• Intervention / Treatment: Device: SelfWrap Bioabsorbable Perivascular Wrap

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Sanatorio Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years, male or female;
2. 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);
3. Target cephalic vein inner diameter ≥ 2.5 mm and target artery ≥ 2.0 mm as measured via duplex ultrasound with a tourniquet applied;
4. For radial AVFs, a nonpathological modified Allen test;
5. Triphasic arterial flow and intact venous outflow;
6. 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.
7. Participant is willing and able to comply with study requirements and sign an informed consent.

Exclusion Criteria:

1. Planned index procedure to revise or repair an existing fistula;
2. 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.
3. Significant (> 50%) stenosis at the target vein on the side of surgery, as diagnosed by preoperative ultrasound;
4. Known central venous stenosis > 50%;
5. Amputated limb;
6. Use of a peripherally-inserted central catheter (PICC) line;
7. Abnormal cardiac rhythm;
8. Known coagulation disorder;
9. Known or suspected active infection at the time of surgery;
10. Congestive heart failure NYHA class 4;
11. Prior steal on the side of surgery;
12. Enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint(s), or was previously enrolled in this study;
13. Life expectancy less than 12 months;
14. Patient expecting to undergo kidney transplant surgery within 12 months of enrollment;
15. 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.
16. Unwillingness or inability to give consent and/or comply with the study follow up schedule.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SelfWrap-treated; Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery	Device: SelfWrap Bioabsorbable Perivascular Wrap; SelfWrap is applied during the normal arteriovenous fistula (AVF) creation procedure. It provides mechanical support to the vein and induces outward remodeling to improve maturation and patency of AVFs.; Other Names: SelfWrap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency	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	Through 6 months post-AVF creation
Cumulative Patency	Proportion of participants with a created AVF that is not abandoned or occluded, through 6 months	Through 6 months post-AVF creation
Freedom from Device-Related Safety Events	Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations	Through 6 months post-AVF creation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency	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 1, 2, 3, and 12 months	Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Cumulative Patency	Proportion of participants with a created AVF that is not abandoned or occluded, through 1, 2, 3, and 12 months	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
Unassisted Physiological Maturation	A created AVF with a proximal arterial flow rate ≥ 500 mL/min and a vein inner diameter ≥ 4.0 mm near the cannulation site, in absence of intervention(s) to initially establish this flow rate and vein size	1, 2, 3, and 6 months post-AVF creation
Freedom from Device-Related Safety Events	Proportion of participants with freedom from device-related infection, thrombosis, aneurysm, pseudoaneurysm, major bleeding, and rehospitalizations	Through 1, 2, 3, 12, 18, and 24 months post-AVF creation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assisted Physiological Maturation	A created AVF with a proximal arterial flow rate ≥ 500 mL/min and a vein inner diameter ≥ 4.0 mm near the cannulation site, which required intervention(s) (e.g. angioplasty) to initially establish this flow rate and vein size	1, 2, 3, and 6 months post-AVF creation
Assisted Primary Patency	Proportion of participants with a created AVF that is not abandoned nor occluded and is free from access thrombosis, through 1, 2, 3, 6, and 12 months	1, 2, 3, 6, 12, 18, and 24 months post-AVF creation
Time-to-Cannulation (or Cumulative Incidence)	The time from AVF creation to the first two-needle hemodialysis through the newly-created AVF, as reported by the clinical research associate or site-designated clinician	Through 12 months
Time-to-Maturation (Functional Maturation)	The duration of time from AVF creation to the first date that the AVF is able to provide prescribed dialysis consistently with two needles for more than two thirds of dialysis sessions within 4 consecutive weeks, as reported by the CRA or site-designated clinician	Through 12 months
Functional Primary Patency	Proportion of participants with a created AVF that is free from thrombosis as well as any intervention required to facilitate, maintain, or reestablish patency (e.g. angioplasty), from the first date that it is able to provide prescribed dialysis consistently with two needles for more than two thirds of dialysis sessions within 4 consecutive weeks (i.e. mature AVF) as reported by the CRA or site-designated clinician, at 2, 3, 6, and 12 months	2, 3, 6, 12, 18, and 24 months
Functional Cumulative Patency	Proportion of participants with a created AVF that is not abandoned or occluded, from the first date that it is able to provide prescribed dialysis consistently with two needles for more than two thirds of dialysis sessions within 4 consecutive weeks as reported by the CRA or site-designated clinician, at 2, 3, 6, and 12 months	2, 3, 6, 12, 18, and 24 months

Collaborators and Investigators

• Sponsor: VenoStent
• Investigators: Principal Investigator: Adrian Ebner, MD, Sanatorio Italiano

Publications and helpful links

Helpful Links

• VenoStent website

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): February 23, 2022
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Chronic Kidney Disease; Dialysis; Hemodialysis; Vascular Access; Bioabsorbable; AVF; Nephrology; Vascular Surgery; Arteriovenous Fistula; Perivascular Wrap; External Support
• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Cardiovascular Abnormalities; Congenital Abnormalities; Urologic Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Vascular Malformations; Fistula; Arteriovenous Malformations; Arteriovenous Fistula; Vascular Fistula
• Other Study ID Numbers: PLN-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes