Study Results
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View full resultsBasic Information
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COMPLETED
NA
211 participants
INTERVENTIONAL
2018-08-07
2019-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cook Enforcer balloon catheter
The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
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
Conventional angioplasty balloon catheters
Commercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Conventional angioplasty balloon catheters
Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
Interventions
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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
Conventional angioplasty balloon catheters
Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cook Research Incorporated
INDUSTRY
Responsible Party
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Locations
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Arizona Kideny Disease & Hypertension Surgery Center
Phoenix, Arizona, United States
The Vascular Experts
Darien, Connecticut, United States
Delaware Kidney/Nephrology Associates, PA
Newark, Delaware, United States
Fairlawn Surgery Center
Roanoke, Virginia, United States
Vascular Institute of Virginia
Woodbridge, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-04
Identifier Type: -
Identifier Source: org_study_id
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