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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, 6, 12, 18, 24, and 36 months post index procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 12, 18, 24, and 36 months post index procedure
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 moreSecondary 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My dialysis access is in my leg.I have untreated narrow veins far from the main problem area.The area to be studied is inside a stent.My target lesion's related blood clot was treated within the last week.The place where the target lesion is located would need the COVERA™ Vascular Covered Stent to be placed where the dialysis needle goes in.I have a working AV fistula in my arm that has been used for dialysis.I have an infection in my AV fistula or another uncontrolled infection.I am at least 21 years old, not pregnant (if female), and expected to live long enough to complete the study.My heart's blocked artery didn't fully open during a balloon procedure.The nearby vein must be between 5.0 and 9.0mm wide.My treatment needs a stent in a central vein or under my collarbone.My target lesion has an aneurysm or pseudoaneurysm.I have a bleeding or blood clotting disorder that is not under control.The area of concern should be no larger than 9 centimeters. It's important to note that there could be more than one narrow area within the main area of concern.You are undergoing dialysis using an AV graft.The target lesion is located in a place that would need a special kind of stent that goes across the elbow joint.I have a blockage in my vein of 50% or more, affecting my AV fistula's function.
Research Study Groups:
This trial has the following groups:- Group 1: COVERA Vascular Covered Stent
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.