SelfWrap-Assisted Arteriovenous Fistulas

NCT05418816 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PLN-030
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Dialysis; Hemodialysis; Chronic Kidney Disease; End Stage Renal Disease; Vascular Surgery; Vascular Access; Arteriovenous Fistula; AVF; Nephrology; Bioabsorbable; Perivascular Wrap; External Support

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Primary Patency

  Through 1, 2, 3, 12, 18, and 24 months post-AVF creation

• Cumulative 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

• Unassisted Physiological Maturation

  1, 2, 3, and 6 months post-AVF creation

• Freedom from Device-Related Safety Events

  Through 1, 2, 3, 12, 18, and 24 months post-AVF creation

Other Outcomes (6)

• Assisted Physiological Maturation

  1, 2, 3, and 6 months post-AVF creation

• Assisted Primary Patency

  1, 2, 3, 6, 12, 18, and 24 months post-AVF creation

• Time-to-Cannulation (or Cumulative Incidence)

  Through 12 months

Study Arms (1)

SelfWrap-treated

EXPERIMENTAL

Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery

Device: SelfWrap Bioabsorbable Perivascular Wrap

Interventions

SelfWrap Bioabsorbable Perivascular Wrap 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.

Also known as: SelfWrap

SelfWrap-treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VenoStent: lead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

Location

Related Links

• VenoStent website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Arteriovenous Fistula; Vascular Diseases; Arteriovenous Malformations; Vascular Malformations; Vascular Fistula; Fistula; Renal Insufficiency; Urologic Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical

Study Officials

• Adrian Ebner, MD

  Sanatorio Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 14, 2022
• Study Start: June 14, 2021
• Primary Completion: February 23, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)