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Cook Enforcer Post-Market Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT03552289

Cook Enforcer Post-Market Study

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 treatme...

Lead sponsor: Cook Research Incorporated•5 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Cook Research Incorporated

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 19, 2020Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment211

Start dateAug 2018

Last updatedOct 19, 2020

Condition

End-Stage Renal Disease

Locations shown

Arizona Kideny Disease & Hypertension Surgery Center

Phoenix, Arizona

The Vascular Experts

Darien, Connecticut

Delaware Kidney/Nephrology Associates, PA

Newark, Delaware

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2020Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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