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Completed

NCT Number: NCT03552289

Cook Enforcer Post-Market Study

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Kideny Disease & Hypertension Surgery Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Conventional angioplasty balloon catheters

Device

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

Primary outcomes

  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, up to approximately 1 hour

    Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 11, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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