Cook Enforcer Post-Market Study
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | August 7, 2018 |
| End Date: | December 1, 2019 |
| Contact: | Amy Theivagt, MS |
| Email: | Amy.Theivagt@cookmedical.com |
| Phone: | 765-463-7537 |
Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis
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.
Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels
compared to treatment with a conventional angioplasty balloon.
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
We found this trial at
5
sites
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