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Stent Graft
Covered Stents for Vascular Narrowing in Hemodialysis Access
N/A
Waitlist Available
Led By Abigail Falk, Dr.
Research Sponsored by American Access Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has lesions that meet the angiographic inclusion/exclusion criteria and induce clinical, hemodynamic, or functional abnormality
Patient is ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is comparing balloon angioplasty (standard of care) to using a covered stent graft to see if the stent decreases the need for angioplasty in the future.
Who is the study for?
Adults over 18 on hemodialysis with mature forearm or upper arm access, who have narrowed veins affecting dialysis and are expected to continue dialysis for at least a year. Participants must understand the study and follow-up requirements. Excluded are those with heparin sensitivity, planned kidney transplants, other trials enrollment, conditions limiting follow-up compliance, certain indwelling catheters, bleeding disorders, contrast allergies, pregnancy or systemic infections.Check my eligibility
What is being tested?
The trial compares balloon angioplasty (standard care) against using a covered stent graft called GORE VIABAHN® in treating vein narrowings in hemodialysis patients. The goal is to see if the stent keeps access open longer with fewer retreatments by checking fistula flow rates at intervals up to one year post-procedure.See study design
What are the potential side effects?
Potential side effects may include local reactions at the treatment site such as pain or swelling, risk of infection, allergic reaction to materials used including heparin if not excluded prior due to known sensitivity; also possible venous rupture from angioplasty.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lesions cause clinical or functional issues and meet specific criteria.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary patency at 3, 6, and 12 months
Secondary outcome measures
Secondary patency at 3, 6, and 12 months
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PTA with covered stentExperimental Treatment1 Intervention
GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Group II: Percutaneous Transluminal Angioplasty (PTA) aloneActive Control1 Intervention
Intervention: Procedure: PTA alone without use of the GORE VIABAHN
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Who is running the clinical trial?
American Access CareLead Sponsor
Abigail Falk, Dr.Principal InvestigatorAmerican Access Care Physician
Claudio Cantu, RPAStudy ChairAmerican Access Care Center Operations Manager
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder like hemophilia.I might have an infection in my dialysis access or in my blood.I might have an infection that affects my whole body.I am scheduled for a kidney transplant from a living donor.My doctor thinks my dialysis access isn't right for a certain type of treatment.I had a vein rupture due to a balloon angioplasty procedure.My dialysis access is blocked by a clot.I am on hemodialysis with a mature access in my arm, created over 2 months ago.My lesions cause clinical or functional issues and meet specific criteria.I am on immunosuppressant medication like rapamycin or prednisone.I have a stent in a central vein that affects my internal jugular vein.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: PTA with covered stent
- Group 2: Percutaneous Transluminal Angioplasty (PTA) alone
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to volunteer in this trial?
"To be considered for this research project, a person needs to have constriction and pathologic symptoms while also being between 18-70 years old. The trial is hoping to enrol 140 people in total."
Answered by AI
Are individuals aged 45 years or older eligible for this research project?
"This medical trial is recruiting patients that are within the age bracket of 18 to 70. For those younger than 18, there are 21 other trials available and 245 studies for individuals above 65 years old."
Answered by AI
Is it still feasible to join this research experiment?
"According to records on clinicaltrials.gov, this research is not presently recruiting participants. Despite being first posted in October 2010 and last updated nearly a year later, no candidates are needed for the study at present. However, there are 254 other studies actively seeking volunteers currently."
Answered by AI
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