Cook Enforcer Post-Market Study

Cook Group

Status: Completed

Conditions: End-Stage Renal Disease

Treatments: Device: Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; Device: Conventional angioplasty balloon catheters

Study type: Interventional

Funder types: Industry

Identifiers

NCT03552289

17-04

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 2 patient groups

Cook Enforcer balloon catheter

Active Comparator group

Description:

The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.

Treatment:

Device: Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Conventional angioplasty balloon catheters

Active Comparator group

Description:

Commercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.

Treatment:

Device: Conventional angioplasty balloon catheters