CompletedNot Applicable

Cook Enforcer Post-Market Study

United States211 participantsStarted 2018-08-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percent of Lesions Requiring Adjunctive Treatment

Timeframe: Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour

Trial details

NCT IDNCT03552289

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-29

Results submitted2020-08-10

View on ClinicalTrials.gov More End-Stage Renal Disease trials