Cook Enforcer Post-Market Study

Cook Research Incorporated211 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

211

Conditions

End-Stage Renal Disease

Interventions

Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon CatheterDEVICE

The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula

Conventional angioplasty balloon cathetersDEVICE

Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Arizona Kideny Disease & Hypertension Surgery Center

Phoenix, Arizona, United States

The Vascular Experts

Darien, Connecticut, United States

Delaware Kidney/Nephrology Associates, PA

Newark, Delaware, United States

Fairlawn Surgery Center

Roanoke, Virginia, United States

Outcomes

Primary Outcomes

Percent of Lesions Requiring Adjunctive Treatment

Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon

Time frame: Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour

Data from ClinicalTrials.gov

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