Trials / Completed
CompletedNCT03552289
Cook Enforcer Post-Market Study
Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- Cook Research Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| DEVICE | Conventional angioplasty balloon catheters | Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula |
Timeline
- Start date
- 2018-08-07
- Primary completion
- 2019-05-29
- Completion
- 2019-08-27
- First posted
- 2018-06-11
- Last updated
- 2020-10-19
- Results posted
- 2020-08-24
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03552289. Inclusion in this directory is not an endorsement.