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Vascular Stent

Vascular Stent for Arteriovenous Fistula

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 be either a male or non-pregnant female ≥ 21 years of age with an expected lifespan sufficient to allow for completion of all study procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 am at least 21 years old, not pregnant (if female), and expected to live long enough to complete the study.
Select...
I have a blockage in my vein of 50% or more, affecting my AV fistula's function.

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

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

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

Who is running the clinical trial?

C. R. BardLead Sponsor
103 Previous Clinical Trials
39,365 Total Patients Enrolled
6 Trials studying Arteriovenous Fistula
1,112 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being accepted for this trial?

"Unfortunately, this particular trial is not currently seeking patients. Although the last update to the study was on September 9th, 2022, it is not looking for participants at this time. However, there are 114 other trials that might be a better fit."

Answered by AI

In how many different places is this trial being run today?

"Enrollment for this study is currently underway at 11 sites, some of which are in New Haven, Minneapolis and Raleigh. To reduce the amount of travel required, patients are encouraged to seek out a location nearest them."

Answered by AI
~21 spots leftby Mar 2025