RECRUITING

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

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Conditions

Chronic Kidney DiseasesEnd Stage Renal DiseaseArteriovenous FistulaHemodialysis Access FailureESRDVascular Access ComplicationRenal FailureCatheter ComplicationsCatheter DysfunctionRenal InsufficiencyVascular SurgeryVascular AccessNephrologyBioabsorbablePerivascular WrapExternal SupportHemodialysisDialysisChronic Kidney DiseaseAVF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Quick Facts

Study Start:2023-11-20
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06001827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age of at least 18 years
  2. * Referred for creation of a new AVF
  3. * Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months
  1. * Planned index procedure to revise or repair an existing fistula
  2. * Target artery inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
  3. * Target vein inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
  4. * 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
  5. * Known central venous stenosis of at least 50% on the side of surgery
  6. * Presence of a stent or a stent graft within the access circuit
  7. * Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation
  8. * Known or suspected active infection at the time of surgery
  9. * Congestive heart failure NYHA class 4
  10. * Prior steal on the side of surgery;
  11. * Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study
  12. * Life expectancy less than 12 months
  13. * Expected to undergo kidney transplant surgery within 6 months of enrollment
  14. * Expected to undergo home hemodialysis
  15. * Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening
  16. * 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
  17. * Unwillingness or inability to give consent and/or comply with the study follow up schedule
  18. * 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

Study Contact

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

Principal Investigator

Timothy Boire, PhD
STUDY_DIRECTOR
VenoStent, Inc.

Study Locations (Sites)

AKDHC Marana Surgery Center
Marana, Arizona, 85658
United States
Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
Phoenix, Arizona, 85012
United States
Banner University Medical Center
Tucson, Arizona, 85724
United States
Lutheran Medical Group
Fort Wayne, Indiana, 46804
United States
University of Missouri
Columbia, Missouri, 65212
United States
Surgical Specialists of Charlotte, PA
Charlotte, North Carolina, 28226
United States
WakeMed
Raleigh, North Carolina, 27610
United States
Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
Orangeburg, South Carolina, 29118
United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
United States
Houston Methodist Research Institute
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: VenoStent

  • Timothy Boire, PhD, STUDY_DIRECTOR, VenoStent, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-20
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-11-20
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • 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

  • Chronic Kidney Diseases
  • End Stage Renal Disease
  • Arteriovenous Fistula
  • Hemodialysis Access Failure
  • ESRD
  • Vascular Access Complication
  • Renal Failure
  • Catheter Complications
  • Catheter Dysfunction
  • Renal Insufficiency