Chronic Kidney DiseasesSAVE-FistulaSNCT06001827
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
A study testing SelfWrap Bioabsorbable Perivascular Wrap in people with Chronic Kidney Diseases and End Stage Renal Disease, run by VenoStent at 28 sites in United States.
Trial summary
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula
- What is being tested?
- SelfWrap Bioabsorbable Perivascular Wrap
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 28 sitesUnited States
- Study dates
- 3 Jan 2024to Dec 2029
- 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 of at least 18 years
- Referred for creation of a new AVF
- Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months
Who cannot join
- Planned index procedure to revise or repair an existing fistula
- Target artery inner diameter < 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
- Target vein inner diameter < 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
- Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound
- Known central venous stenosis of at least 50% on the side of surgery
- Presence of a stent or a stent graft within the access circuit
Show all 18Show fewer
- Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation
- 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, or was previously enrolled in this study
- Life expectancy less than 12 months
- Expected to undergo kidney transplant surgery within 6 months of enrollment
- Expected to undergo home hemodialysis
- Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening
- Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study
- Unwillingness or inability to give consent and/or comply with the study follow up schedule
- Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
United States28 sites, 28 recruiting
- Recruiting
Saint David's HealthCare Partnership, L.P., LLP
Austin, Texas, 78701
Shir Yelovitch, PhD, (512) 459-3300 ext. 214, SYelovitch@ctvstexas.com
Ryan Turley, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Navya Kotturu, nkotturu@bwh.harvard.edu
Danielle Montano, dmontano2@bwh.harvard.edu
- Recruiting
AKDHC Bullhead City
Bullhead City, Arizona, 86442
Cynthia Carrizoza, ccarrizoza@akdhc.com
Rick Mishler, MD
- Recruiting
MUSC Charleston
Charleston, South Carolina, 29425
Natalie Koren, korenn@musc.edu
Adam Tanious, MD
- Recruiting
Surgical Specialists of Charlotte, P.A.
Charlotte, North Carolina, 28226
Decca Taylor, (704) 945-3560, dtaylor@ssclt.com
Crystal Turner, cturner@ssclt.com
- Recruiting
University of Missouri
Columbia, Missouri, 65212
Brianna Ledbetter, 573-882-4387, balg34@health.missouri.edu
Jennifer Randolph, 573-882-4387, randolphjl@health.missouri.edu
- Recruiting
Vascular Care of South Carolina
Columbia, South Carolina, 29203
Alicia Phillips-Pough, RN, 803-252-3373, alicia.phillips-pough@azuracare.com
Dion Franga, MD
- Recruiting
A&V Doctors PLLC
El Paso, Texas, 79912
Joshua Crawford, 915-307-7800, jcrawford@arteriesveins.com
Emmanuel Anekwe, MD
- Recruiting
MUSC Black River
Florence, South Carolina, 29505
Patricia Robinson, robinpat@musc.edu
Tannesha Clements, clemtann@musc.edu
- Recruiting
Lutheran Medical Group
Fort Wayne, Indiana, 46804
Barbara Anderson, 260-458-3555, banderson2@lutheran-hosp.com
Sharon Eichman
- Recruiting
Orange County Vascular Access Center
Garden Grove, California, 92840
Nicole Hilton, 803-252-3373, Nicole.Hilton@azuracare.com
Steven Posner, MD
- Recruiting
Prisma Health
Greenville, South Carolina, 29615
Kya Spann, Kya.Spann@prismahealth.org
Nikita Kasinger, Nikita.Kasinger@PrismaHealth.org
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Caroline Antunes, cantunes@houstonmethodist.org
Eric Peden, MD
- Recruiting
Northwell Health
Lake Success, New York, 11042
Victoria Wairimu, mwairimu@northwell.edu
Yana Etkin, MD
- Recruiting
Surgical Associates of Lexington
Lexington, Kentucky, 40503
Amanda Gaddis, gaddisak@yahoo.com
Colby Atkins, MD
- Recruiting
AKDHC Marana Surgery Center
Marana, Arizona, 85658
Anell S Munoz Gallego, amgallego@akdhc.com
Zhongguang (Ziggy) Yang, MD, PhD
- Recruiting
James Eric Gardner, MD, PC
Memphis, Tennessee, 38115
Hannah Gardner, 901-493-7821, hannahgardner3@gmail.com
James E Gardner, MD
- Recruiting
Upper Valley Dialysis Access Center, LLC
Mission, Texas, 78572
Martha Perez, 956-600-8899, martha.perez@uvdac.com
Chijoke Ogbu, MD
- Recruiting
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
Orangeburg, South Carolina, 29118
Virginia Anderson, (803) 395-3878, andersvi@musc.edu
Amy Lawson, lawsoamy@musc.edu
- Recruiting
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
Phoenix, Arizona, 85012
Cynthia Carrizoza, (602) 200-8288, ccarrizoza@akdhc.com
Shouwen Wang, MD, PhD
- Recruiting
WakeMed
Raleigh, North Carolina, 27610
Jenna Cassels, 919-350-5252, jcassels@wakemed.org
Rhonda Norton
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jess Schneider, 507-284-2511, schneider.jessica1@mayo.edu
Randall DeMartino, MD
- Recruiting
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29650
Darla Howard, DHoward@srhs.com
Shannon Stancil, SStancil@srhs.com
- Recruiting
Saint Louis University
St Louis, Missouri, 63104
Kathryn Lindsay, kathryn.lindsay@health.slu.edu
Craig Dedert, craig.dedert@health.slu.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Ashley Cosentino, ashley.cosentino@wustl.edu
Laura McDonald, m.laura@wustl.edu
- Recruiting
Houston Methodist Research Institute (Sugar Land)
Sugar Land, Texas, 77479
Sheila Moore, srmoore@houstonmethodist.org
Eric Peden, MD
- Recruiting
Tallahassee Research Institute
Tallahassee, Florida, 32308
Brianna Everett, hopefullybrianna@gmail.com
Andres Vargas, MD
- Recruiting
Banner University Medical Center
Tucson, Arizona, 85724
Jennifer Lopez, jpinedalopez@arizona.edu
Wei Zhou, MD
About this study
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
Read the detailed description
This is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded clinical trial for CKD patients referred for creation of a new arteriovenous fistula (AVF). This study will involve approximately 600 participants from up to 30 investigational sites, randomized 1:1 to treatment with the SelfWrap or the untreated AVF control (i.e. standard of care, SOC). Participants will be followed for a duration of 36 months.
- Conditions
- Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure, ESRD, Vascular Access Complication
- Being tested
- SelfWrap Bioabsorbable Perivascular Wrap, Untreated AVF Control
- Keywords
- Vascular Surgery, Vascular Access, Nephrology, Bioabsorbable, Perivascular Wrap, External Support, Hemodialysis, Dialysis, Chronic Kidney Disease, End Stage Renal Disease, Arteriovenous Fistula, AVF
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Arteriovenous Fistula, Renal Insufficiency
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 arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
Untreated AVF ControlProcedure or surgery
Also called Standard of Care
AVF creation surgery without any intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery Receives: Device: SelfWrap Bioabsorbable Perivascular Wrap |
| Control Arm | Sham comparator | AVF creation surgery without any intervention (untreated AVF control, or standard of care) Receives: Procedure: Untreated AVF Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unassisted Maturation by 180 days
A participant who is either 1) on hemodialysis on or before day 150 and the AVF has been cannulated with two needles for at least 75% of dialysis sessions within any 4 consecutive week period to achieve the prescribed dialysis by the 180 day follow up, and did not require any facilitative endovascular or surgical intervention to achieve this, or 2) is not on hemodialysis on or before day 150, but ultrasound measurements by the 180 day follow up indicate a proximal arterial flow rate of at least 500 mL/min and a vein inner diameter of at least 5.0 mm at 5 - 8 cm from the anastomosis, and did not require any facilitative endovascular or surgical intervention through the 180 day follow up.
Measured: Assessed at up to 6 months
Freedom from access-related adverse events through 30 days
Freedom from access-related adverse events through 30 days
Measured: Assessed through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start3 Jan 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2029 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VenoStent
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Boire, PhD, Study director, VenoStent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001827
- Sponsor's protocol ID
- VENO-CIP002
- Acronym
- SAVE-FistulaS
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2023
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
- ClinicalTrials.gov ID
- NCT06001827
- Acronym / sponsor ID
- SAVE-FistulaS / VENO-CIP002
- Conditions
- Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure, ESRD, Vascular Access Complication
- Keywords
- Vascular Surgery, Vascular Access, Nephrology, Bioabsorbable, Perivascular Wrap, External Support, Hemodialysis, Dialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- VenoStentIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Aug 2023 (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 prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
Detailed description
This is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded clinical trial for CKD patients referred for creation of a new arteriovenous fistula (AVF). This study will involve approximately 600 participants from up to 30 investigational sites, randomized 1:1 to treatment with the SelfWrap or the untreated AVF control (i.e. standard of care, SOC). Participants will be followed for a duration of 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: SelfWrap Bioabsorbable Perivascular WrapTreated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery |
| Control Arm | Sham comparator | Procedure: Untreated AVF ControlAVF creation surgery without any intervention (untreated AVF control, or standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of at least 18 years
- Referred for creation of a new AVF
- Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months
Key exclusion criteria (18 listed)
- Planned index procedure to revise or repair an existing fistula
- Target artery inner diameter < 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
- Target vein inner diameter < 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
- Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound
- Known central venous stenosis of at least 50% on the side of surgery
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 arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs. | Device | Treatment Arm |
| Untreated AVF ControlAlso: Standard of CareAVF creation surgery without any intervention | Procedure or surgery | Control Arm |
Primary outcome
Unassisted Maturation by 180 days
Time frame: Assessed at up to 6 months
A participant who is either 1) on hemodialysis on or before day 150 and the AVF has been cannulated with two needles for at least 75% of dialysis sessions within any 4 consecutive week period to achieve the prescribed dialysis by the 180 day follow up, and did not require any facilitative endovascular or surgical intervention to achieve this, or 2) is not on hemodialysis on or before day 150, but ultrasound measurements by the 180 day follow up indicate a proximal arterial flow rate of at least 500 mL/min and a vein inner diameter of at least 5.0 mm at 5 - 8 cm from the anastomosis, and did not require any facilitative endovascular or surgical intervention through the 180 day follow up.
Freedom from access-related adverse events through 30 days
Time frame: Assessed through 30 days
Freedom from access-related adverse events through 30 days
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 17 Feb 2026.
- SAVE-FistulaS websiteLink provided by the sponsor.
- 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.
Timothy Boire, PhD study director
VenoStent, Inc.
28 sites 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 End Stage Renal Disease, run by VenoStent at 28 sites in United States.
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 3 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Contact Mark Barakat, MD ((832) 429-5362, mark.barakat@venostent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unassisted Maturation by 180 days (time frame: Assessed at up to 6 months). The study lists 2 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 17 Feb 2026.