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Cook Enforcer Post-Market Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552289
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( 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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Device: Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Device: Conventional angioplasty balloon catheters Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis
Actual Study Start Date : August 7, 2018
Actual Primary Completion Date : May 29, 2019
Actual Study Completion Date : August 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Active Comparator: Cook Enforcer balloon catheter
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
The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula

Active Comparator: Conventional angioplasty balloon catheters
Commercial 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
Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula




Primary Outcome Measures :
  1. Percent of lesions requiring adjunctive treatment [ Time Frame: immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft ]
    Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552289


Locations
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United States, Arizona
Arizona Kideny Disease & Hypertension Surgery Center
Phoenix, Arizona, United States, 85012
United States, Connecticut
The Vascular Experts
Darien, Connecticut, United States, 06820
United States, Delaware
Delaware Kidney/Nephrology Associates, PA
Newark, Delaware, United States, 19713
United States, Virginia
Fairlawn Surgery Center
Roanoke, Virginia, United States, 24014
Vascular Institute of Virginia
Woodbridge, Virginia, United States, 22193
Sponsors and Collaborators
Cook Research Incorporated

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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT03552289     History of Changes
Other Study ID Numbers: 17-04
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Dialysis
Renal
Hemodialysis
Stenosis(es)
Transluminal
Percutaneous Transluminal Angioplasty
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency