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SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study (SAVE-FistulaS)

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ClinicalTrials.gov Identifier: NCT06001827
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : November 22, 2023
Sponsor:
Information provided by (Responsible Party):
VenoStent

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases End Stage Renal Disease Arteriovenous Fistula Hemodialysis Access Failure ESRD Vascular Access Complication Renal Failure Catheter Complications Catheter Dysfunction Renal Insufficiency Device: SelfWrap Bioabsorbable Perivascular Wrap Procedure: Untreated AVF Control Not Applicable

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 200 participants from up to 20 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
Estimated Study Start Date : November 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm
Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
 Device: SelfWrap Bioabsorbable Perivascular Wrap
SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
Other Name: SelfWrap
Sham Comparator: Control Arm
AVF creation surgery without any intervention (untreated AVF control, or standard of care)
 Procedure: Untreated AVF Control
AVF creation surgery without any intervention
Other Name: Standard of Care


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Freedom from access-related adverse events through 30 days [ Time Frame: Assessed through 30 days ]
    Freedom from access-related adverse events through 30 days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001827


Contacts
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Contact: Mark Barakat, MD (832) 429-5362 mark.barakat@venostent.com

Locations
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United States, North Carolina
Surgical Specialists of Charlotte, PA Recruiting
Charlotte, North Carolina, United States, 28226
Contact: Decca Taylor    704-945-3560    dtaylor@ssclt.com   
Principal Investigator: Jason Burgess, MD         
United States, Texas
Cardiothoracic and Vascular Surgeons Recruiting
Austin, Texas, United States, 78756
Contact: Shir Yelovitch, PhD    512-459-3300 ext 214    SYelovitch@ctvstexas.com   
Principal Investigator: Ryan Turley, MD         
Sponsors and Collaborators
VenoStent
Investigators
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Study Director: Timothy Boire, PhD VenoStent, Inc.
More Information
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Additional Information:

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Responsible Party: VenoStent
ClinicalTrials.gov Identifier: NCT06001827    
Other Study ID Numbers: VENO-CIP002
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: November 22, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by VenoStent:
Vascular Surgery
Vascular Access
Nephrology
Bioabsorbable
Perivascular Wrap
External Support
 Hemodialysis
Dialysis
Chronic Kidney Disease
End Stage Renal Disease
Arteriovenous Fistula
AVF
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Renal Insufficiency
Arteriovenous Fistula
Fistula
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities