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Vascular Stent

Vascular Stent for Arteriovenous Fistula

Phoenix, AZ
N/A
Waitlist Available
Led By Bart Dolmatch, M.D.
Research Sponsored by C. R. Bard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have an upper extremity AV fistula that has undergone at least one successful dialysis session with two-needle cannulation, prior to the index procedure.
Subject must have angiographic evidence of a stenosis ≥ 50% (by visual estimation) located in the venous outflow of the AV access circuit and present with clinical or hemodynamic evidence of AV fistula dysfunction.
Must not have
The hemodialysis access is located in the lower extremity.
The subject has a known uncontrolled blood coagulation/bleeding disorder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at the safety and effectiveness of a stent to treat narrowed blood vessels in the upper extremities of people with AV access.

Who is the study for?
This trial is for adults over 21 with arteriovenous fistulas in the upper extremity used for dialysis, who've had at least one successful session. Participants must have a vein size of 5.0-9.0mm and a stenosis ≥50% causing dysfunction. Exclusions include lower extremity AV access, allergies to certain metals or contrast media, recent thrombosis treatment, uncontrolled infections or bleeding disorders.
What is being tested?
The study aims to gather safety and effectiveness data on the COVERA Vascular Covered Stent when treating narrowed blood vessels in venous outflow from arteriovenous (AV) access circuits in patients undergoing hemodialysis.
What are the potential side effects?
Potential side effects may include local reactions at the stent placement site, issues related to blood flow changes due to the stent's presence, allergic reactions if sensitivity to stent materials exists, and complications from obstructing necessary vessel areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a working AV fistula in my arm that has been used for dialysis.
Select...
I have a blockage in my vein of 50% or more, affecting my AV fistula's function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My dialysis access is in my leg.
Select...
I have a bleeding or blood clotting disorder that is not under control.
Select...
I have untreated narrow veins far from the main problem area.
Select...
I have an infection in my AV fistula or another uncontrolled infection.
Select...
My treatment needs a stent in a central vein or under my collarbone.
Select...
My target lesion has an aneurysm or pseudoaneurysm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 12, 18, 24, and 36 months post index procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 12, 18, 24, and 36 months post index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Access Circuit Primary Patency (ACPP)
Acute Procedural Success
Acute Technical Success for Stent Graft Placement
+8 more
Secondary study objectives
Rate of Device and Procedure Related Adverse Events involving the access circuit.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: COVERA Vascular Covered StentExperimental Treatment1 Intervention
COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of hemodialysis subjects dialyzing with an AV fistula.

Find a Location

Closest Location:Arizona Kidney Disease and Hypertension Center Medical Research Services· Phoenix, AZ

Who is running the clinical trial?

C. R. BardLead Sponsor
106 Previous Clinical Trials
39,851 Total Patients Enrolled
6 Trials studying Arteriovenous Fistula
1,119 Patients Enrolled for Arteriovenous Fistula
Bart Dolmatch, M.D.Principal InvestigatorThe Palo Alto Medical Foundation
2 Previous Clinical Trials
390 Total Patients Enrolled

Media Library

Covera Vascular Covered Stent (Vascular Stent) Clinical Trial Eligibility Overview. Trial Name: NCT04261686 — N/A
Arteriovenous Fistula Research Study Groups: COVERA Vascular Covered Stent
Arteriovenous Fistula Clinical Trial 2023: Covera Vascular Covered Stent Highlights & Side Effects. Trial Name: NCT04261686 — N/A
Covera Vascular Covered Stent (Vascular Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04261686 — N/A
~12 spots leftby Nov 2025