NCT03552289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 7, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 24, 2020

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

May 17, 2018

Results QC Date

August 10, 2020

Last Update Submit

September 23, 2020

Conditions

End-Stage Renal Disease

Keywords

DialysisRenalHemodialysisStenosis(es)TransluminalPercutaneous Transluminal Angioplasty

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Cook Enforcer balloon catheter

ACTIVE COMPARATOR

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

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

Conventional angioplasty balloon catheters

ACTIVE COMPARATOR

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

Device: Conventional angioplasty balloon catheters

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

Cook Enforcer balloon catheter
Conventional angioplasty balloon cathetersDEVICE

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

Conventional angioplasty balloon catheters

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical or physiological abnormalities which indicate dialysis access dysfunction (e.g., decreased access blood flow, elevated venous pressure, decreased dialysis dose, abnormal physical exam)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Arizona Kideny Disease & Hypertension Surgery Center

Phoenix, Arizona, 85012, United States

Location

The Vascular Experts

Darien, Connecticut, 06820, United States

Location

Delaware Kidney/Nephrology Associates, PA

Newark, Delaware, 19713, United States

Location

Fairlawn Surgery Center

Roanoke, Virginia, 24014, United States

Location

Vascular Institute of Virginia

Woodbridge, Virginia, 22193, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Alan Saunders
Organization
Cook Research Incorporated
Alan.Saunders@CookMedical.com
765-463-7537

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

June 11, 2018

Study Start

August 7, 2018

Primary Completion

May 29, 2019

Study Completion

August 27, 2019

Last Updated

October 19, 2020

Results First Posted

August 24, 2020

Record last verified: 2020-09

Locations

US(5)