Loading clinical trials...

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

COMPLETEDNA

Cook Enforcer Post-Market Study

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

NCT03552289•Cook Research Incorporated

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Vascular Institute of Virginia

Woodbridge, Virginia, United States

Key Dates

Start Date

August 7, 2018

Primary Completion Date

May 29, 2019

Completion Date

August 27, 2019

Last Updated

October 19, 2020

Enrollment

211

ACTUAL participants

Conditions

End-Stage Renal Disease

Interventions

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

DEVICE

Conventional angioplasty balloon catheters

DEVICE

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

NCT04634916

Kidney Disease, End-StageEnd-stage Renal Disease+1 more

View study

RECRUITINGPHASE3

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

NCT06933472

HyperphosphatemiaChronic Kidney Disease, Receiving Dialysis+2 more

View study

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: March 29, 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.

View ClinicalTrials.gov Terms and Conditions

Cook Enforcer Post-Market Study

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

Comparative Study of Prognosis and QOL Between APD-RPM and CAPD

IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure