End-Stage Renal Disease
Conditions
Keywords
Dialysis, Renal, Hemodialysis, Stenosis(es), Transluminal, Percutaneous Transluminal Angioplasty
Brief 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.
Interventions
DEVICECook 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
DEVICEConventional angioplasty balloon catheters
Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
Sponsors
Cook Research Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Lesions Requiring Adjunctive Treatment | Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour | Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 102 |
| Conventional Angioplasty Balloon Catheters Commercial available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
Conventional angioplasty balloon catheters: Commercial available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula | 109 |
| Total | 211 |
Baseline characteristics
| Characteristic | Conventional Angioplasty Balloon Catheters | Total | Cook Enforcer Balloon Catheter |
|---|---|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 12.8 | 65.5 years STANDARD_DEVIATION 12.6 | 65.5 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 20 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 190 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 86 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) White | 57 Participants | 108 Participants | 51 Participants |
| Sex: Female, Male Female | 51 Participants | 94 Participants | 43 Participants |
| Sex: Female, Male Male | 58 Participants | 117 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 102 | 2 / 109 |
| other Total, other adverse events | 24 / 102 | 23 / 109 |
| serious Total, serious adverse events | 2 / 102 | 1 / 109 |
Outcome results
Primary
Percent of Lesions Requiring Adjunctive Treatment
Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon
Time frame: Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Cook Enforcer Balloon Catheter | Percent of Lesions Requiring Adjunctive Treatment | 30 Lesions |
| Conventional Angioplasty Balloon Catheters | Percent of Lesions Requiring Adjunctive Treatment | 26 Lesions |
p-value: 0.8283One-sided Z-test