Chronic Kidney DiseasesSW-AVFNCT05418816

SelfWrap-Assisted Arteriovenous Fistulas

A study testing SelfWrap Bioabsorbable Perivascular Wrap in people with Chronic Kidney Diseases and Chronic Kidney Failure, run by VenoStent at 1 site in Paraguay.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease
What is being tested?: SelfWrap Bioabsorbable Perivascular Wrap
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteParaguay
Study dates: 14 Jun 2021to Sep 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Paraguay1 site

Sanatorio Italiano
Asunción

Other trials in Paraguay

About this study

Official title: 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).

Conditions: Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease, Arteriovenous Fistula, Hemodialysis Access Failure
Being tested: SelfWrap Bioabsorbable Perivascular Wrap
Keywords: Dialysis, Hemodialysis, Chronic Kidney Disease, End Stage Renal Disease, Vascular Surgery, Vascular Access, Arteriovenous Fistula, AVF, Nephrology, Bioabsorbable, Perivascular Wrap, External Support
Medical subject headings: Renal Insufficiency, Chronic, Kidney Failure, Chronic, Arteriovenous Fistula, Vascular Diseases, Arteriovenous Malformations, Vascular Malformations, Vascular Fistula, Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelfWrap Bioabsorbable Perivascular WrapDevice
Also called SelfWrap
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.

Study groups in NCT05418816
Study group	Role	What they receive
SelfWrap-treated	Experimental	Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery Receives: Device: SelfWrap Bioabsorbable Perivascular Wrap

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Through 6 months post-AVF creation
Cumulative Patency
Proportion of participants with a created AVF that is not abandoned or occluded, through 6 months
Measured: 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
Measured: Through 6 months post-AVF creation

Secondary outcomes (5)

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
Measured: 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
Measured: Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Number of Interventions
Measured: 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
Measured: 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
Measured: Through 1, 2, 3, 12, 18, and 24 months post-AVF creation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 2021Sep 2026

First posted14 Jun 2022
Study start14 Jun 2021
Primary completion23 Feb 2022
Study completionSep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05418816
Sponsor's protocol ID: PLN-030
Acronym: SW-AVF
Status last verified: Mar 2025
First submitted: 7 Jun 2022
Last updated: 1 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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