What side effects are associated with this type of intervention?

Common treatments for hemodialysis access issues, such as angioplasty and covered stent grafts, can have side effects including infection at the insertion site, bleeding, and thrombosis. There are also risks of stent migration or fracture, and potential allergic reactions to the materials used in the stent graft. Angioplasty often leads to renarrowing of the vein, necessitating repeated treatments, while covered stent grafts aim to provide longer-lasting support and reduce the need for frequent interventions.

What prior FDA approvals exist?

The FDA has approved several treatments for hemodialysis access issues, including covered stent grafts. These devices, such as the Gore Viabahn Endoprosthesis and the Fluency Plus Stent Graft, are designed to provide structural support to veins and prevent renarrowing (restenosis) in hemodialysis patients. These stent grafts are used to treat stenosis in the venous outflow of arteriovenous (AV) grafts and fistulas, helping to maintain the patency and functionality of the dialysis access.

What other types of research exist?

Promising novel alternatives to Covered Stent Grafts for hemodialysis patients include drug-coated balloons, which deliver antiproliferative drugs to the vessel wall to prevent re-narrowing, and bioresorbable vascular scaffolds, which provide temporary support and then dissolve, reducing long-term complications. Additionally, advancements in gene therapy and regenerative medicine are being explored to enhance vascular healing and reduce stenosis recurrence.

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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

Must not have

Patient has a known or suspected systemic infection

Patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two treatments for keeping blood vessels open in dialysis patients: the usual balloon procedure and a new tube-like device called a covered stent graft. The study aims to see if the new device helps keep the vessels open longer and reduces the need for repeat treatments. The new device has shown promise in improving the durability of treatments for dialysis patients.

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.

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.

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 below

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My lesions cause clinical or functional issues and meet specific criteria.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I might have an infection that affects my whole body.

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I am on immunosuppressant medication like rapamycin or prednisone.

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I have a bleeding disorder like hemophilia.

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I might have an infection in my dialysis access or in my blood.

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I have a stent in a central vein that affects my internal jugular vein.

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I had a vein rupture due to a balloon angioplasty procedure.

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My dialysis access is blocked by a clot.

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I am scheduled for a kidney transplant from a living donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary patency at 3, 6, and 12 months

Secondary study objectives

Secondary patency at 3, 6, and 12 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

In hemodialysis, one common issue is the narrowing of veins, particularly in the cephalic arch and central veins, which can impede blood flow and reduce the effectiveness of dialysis. Balloon angioplasty is a standard treatment that temporarily widens these narrowed segments, but they often renarrow within a few months. Covered stent grafts provide a more durable solution by offering structural support to the vein and preventing renarrowing, thereby maintaining better blood flow for a longer period. This is crucial for hemodialysis patients as it reduces the frequency of interventions needed to keep their dialysis access functional, improving their overall treatment experience and outcomes.