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Device

SelfWrap for Chronic Kidney Disease (SAVE-FistulaS Trial)

N/A
Recruiting
Research Sponsored by VenoStent
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of at least 18 years
Referred for creation of a new AVF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at up to 6 months

Summary

This trial studies a new wrap to improve safety & effectiveness of fistula creation for CKD patients.

Who is the study for?
This trial is for adults over 18 with chronic kidney disease who need a new arteriovenous fistula (AVF) for hemodialysis. Participants must be able to follow the study plan and attend check-ups for 3 years.
What is being tested?
The study compares the safety and effectiveness of a new bioabsorbable wrap called SelfWrap applied around an AVF, versus standard care without this wrap in patients undergoing AVF creation.
What are the potential side effects?
Potential side effects may include local reactions at the site where the AVF is created, such as infection, pain, or inflammation due to the SelfWrap material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am referred for a new arteriovenous fistula creation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Freedom from access-related adverse events through 30 days
Unassisted Maturation by 180 days

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
Group II: Control ArmPlacebo Group1 Intervention
AVF creation surgery without any intervention (untreated AVF control, or standard of care)

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Who is running the clinical trial?

VenoStentLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Timothy Boire, PhDStudy DirectorVenoStent, Inc.
~67 spots leftby Jun 2025
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