Cook Enforcer Post-Market Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional angioplasty balloon.

Official Title
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Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Device: Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
* Device: Conventional angioplasty balloon catheters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical or physiological abnormalities which indicate dialysis access dysfunction (e.g., decreased access blood flow, elevated venous pressure, decreased dialysis dose, abnormal physical exam) Exclusion Criteria: Less than 18 years old Pregnant, lactating, or planning to become pregnant in the 3 months following enrollment Underwent any surgical or interventional procedure of the access circuit less than or equal to 30 days prior to enrollment Scheduled for a kidney transplant Stent or stent graft in the arteriovenous (AV) dialysis access circuit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cook Enforcer balloon catheter<br>The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. | Device: Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter<br>* The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula<br>|
| Active Comparator: Conventional angioplasty balloon catheters<br>Commercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. | Device: Conventional angioplasty balloon catheters<br>* Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Lesions Requiring Adjunctive Treatment | Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon | Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Dialysis, Renal, Stenosis(es), Transluminal, Percutaneous Transluminal Angioplasty