CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 211 enrolled
Drug / intervention
Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03552289
NCT03552289N/ACompleted
CompareCT.gov

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

Cook Research Incorporated·interventional·Posted Jun 11, 2018·Updated Oct 19, 2020

In Brief

A clinical study evaluating Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and Conventional angioplasty balloon catheters for End-Stage Renal Disease. Completed, enrolled 211 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd-Stage Renal Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 11, 2018
Enrollment StartAug 7, 2018
Primary CompletionMay 29, 2019
Study CompletionAug 27, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.1 years ago

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