Cook Enforcer Post-Market Study

Not Applicable

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Device: Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; Device: Conventional angioplasty balloon catheters

• Registration Number: NCT03552289
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-11
• Study Start: 2018-08-07
• Primary Completion: 2019-05-29
• Study Completion: 2019-08-27
• Results First Submitted: 2020-08-10
• Results First Submitted QC: 2020-08-10
• Results First Posted: 2020-08-24
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cook Enforcer balloon catheter	Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter	The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Conventional angioplasty balloon catheters	Conventional angioplasty balloon catheters	Commercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.

Primary Outcome Measures

Name	Time	Method
Percent of Lesions Requiring Adjunctive Treatment	Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour	Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon

Trial Locations

Locations (5)

Fairlawn Surgery Center; 🇺🇸 Roanoke, Virginia, United States

Arizona Kideny Disease & Hypertension Surgery Center; 🇺🇸 Phoenix, Arizona, United States

The Vascular Experts; 🇺🇸 Darien, Connecticut, United States

Vascular Institute of Virginia; 🇺🇸 Woodbridge, Virginia, United States

Delaware Kidney/Nephrology Associates, PA; 🇺🇸 Newark, Delaware, United States