SelfWrap-Assisted Arteriovenous Fistulas

NCT ID: NCT05418816

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-14
• Study Completion Date: 2026-09-30

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).

Conditions

Chronic Kidney Diseases; Chronic Kidney Failure; End Stage Renal Disease; End Stage Kidney Disease; Arteriovenous Fistula; Hemodialysis Access Failure; Catheter Complications; Catheter Dysfunction; Vascular Diseases; Arteriovenous Malformations; Vascular Malformations; Vascular Fistula; Fistula; Renal Insufficiency; Renal Failure; Renal Failure Chronic; Urologic Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SelfWrap-treated

Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery

Group Type: EXPERIMENTAL

SelfWrap Bioabsorbable Perivascular Wrap

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

SelfWrap

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VenoStent

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Ebner, MD

Role: PRINCIPAL_INVESTIGATOR

Sanatorio Italiano

Locations

Sanatorio Italiano

Asunción, , Paraguay

Countries

Paraguay

Related Links

https://www.venostent.com

VenoStent website

Other Identifiers

PLN-030

Identifier Type: -

Identifier Source: org_study_id