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.
Trial 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). Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- VenoStent
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, MD, Principal investigator, Sanatorio Italiano
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Feasibility Study of SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)
- ClinicalTrials.gov ID
- NCT05418816
- Acronym / sponsor ID
- SW-AVF / PLN-030
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease, Arteriovenous Fistula, Hemodialysis Access Failure
- Keywords
- Dialysis, Hemodialysis, Chronic Kidney Disease, End Stage Renal Disease, Vascular Surgery, Vascular Access, Arteriovenous Fistula, AVF
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VenoStentIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SelfWrap-treated | Experimental | Device: SelfWrap Bioabsorbable Perivascular WrapTreated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelfWrap Bioabsorbable Perivascular WrapAlso: SelfWrapSelfWrap 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. | Device | SelfWrap-treated |
Primary outcome
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
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
5 secondary outcomes
Primary Patency
Time frame: Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Cumulative Patency
Time frame: Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Number of Interventions
Time frame: Through 1, 2, 3, 6, 12, 18, and 24 months post-AVF creation
Unassisted Physiological Maturation
Time frame: 1, 2, 3, and 6 months post-AVF creation
Freedom from Device-Related Safety Events
Time frame: Through 1, 2, 3, 12, 18, and 24 months post-AVF creation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- VenoStent websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Ebner, MD principal investigator
Sanatorio Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency (time frame: Through 6 months post-AVF creation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.