Cook Enforcer Post-Market Study



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:August 7, 2018
End Date:December 1, 2019
Contact:Amy Theivagt, MS
Email:Amy.Theivagt@cookmedical.com
Phone:765-463-7537

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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

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.


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
We found this trial at
5
sites
85 Old Kings Highway North
Darien, Connecticut 06820
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Darien, CT
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Newark, DE
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Phoenix, AZ
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Roanoke, Virginia 24014
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Roanoke, VA
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14085 Crown Court
Woodbridge, Virginia 22193
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Woodbridge, VA
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