Cook Enforcer Post-Market Study

Completed · Not applicable

Conditions studied: End-Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT03552289

Run by

Cook Research Incorporated

People needed

211

Starts

2018-08-07

Expected to finish

2019-08-27

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical or physiological abnormalities which indicate dialysis access dysfunction (e.g., decreased access blood flow, elevated venous pressure, decreased dialysis dose, abnormal physical exam)

You may not qualify if…

• 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

Where it is running

• 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
• Vascular Institute of Virginia — Woodbridge, Virginia, United States

Full record on ClinicalTrials.gov

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