N/A
Completed N=211
Cook Enforcer Post-Market Study
Source: ClinicalTrials.gov NCT03552289 ↗Enrolled (actual)
211
Serious AEs
1.4%
Results posted
Aug 2020
Primary outcomePrimary: Percent of Lesions Requiring Adjunctive Treatment — 30; 26 Lesions — p=0.8283
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Lesions Requiring Adjunctive Treatment |
30; 26 | 0.8283 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03552289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.