Cook Enforcer Post-Market Study

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552289
• Other study ID #: 17-04
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: August 27, 2019

Study information

• Verified date: September 2020
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: August 27, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
• Conventional angioplasty balloon catheters
Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula

Locations

Country	Name	City	State
United States	The Vascular Experts	Darien	Connecticut
United States	Delaware Kidney/Nephrology Associates, PA	Newark	Delaware
United States	Arizona Kideny Disease & Hypertension Surgery Center	Phoenix	Arizona
United States	Fairlawn Surgery Center	Roanoke	Virginia
United States	Vascular Institute of Virginia	Woodbridge	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

Outcome

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