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Cook Enforcer Post-Market Study

Primary Purpose

End-Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Conventional angioplasty balloon catheters
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring Dialysis, Renal, Hemodialysis, Stenosis(es), Transluminal, Percutaneous Transluminal Angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Arizona Kideny Disease & Hypertension Surgery Center
  • The Vascular Experts
  • Delaware Kidney/Nephrology Associates, PA
  • Fairlawn Surgery Center
  • Vascular Institute of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cook Enforcer balloon catheter

Conventional angioplasty balloon catheters

Arm Description

The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.

Commercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.

Outcomes

Primary Outcome Measures

Percent of Lesions Requiring Adjunctive Treatment
Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon

Secondary Outcome Measures

Full Information

First Posted
May 17, 2018
Last Updated
September 23, 2020
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03552289
Brief Title
Cook Enforcer Post-Market Study
Official Title
Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
May 29, 2019 (Actual)
Study Completion Date
August 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
Dialysis, Renal, Hemodialysis, Stenosis(es), Transluminal, Percutaneous Transluminal Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cook Enforcer balloon catheter
Arm Type
Active Comparator
Arm Description
The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Arm Title
Conventional angioplasty balloon catheters
Arm Type
Active Comparator
Arm Description
Commercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Intervention Type
Device
Intervention Name(s)
Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Intervention Description
The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
Intervention Type
Device
Intervention Name(s)
Conventional angioplasty balloon catheters
Intervention Description
Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
Primary Outcome Measure Information:
Title
Percent of Lesions Requiring Adjunctive Treatment
Description
Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon
Time Frame
Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Arizona Kideny Disease & Hypertension Surgery Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
The Vascular Experts
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Delaware Kidney/Nephrology Associates, PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Fairlawn Surgery Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Vascular Institute of Virginia
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22193
Country
United States

12. IPD Sharing Statement

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Cook Enforcer Post-Market Study

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