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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cook Enforcer balloon catheter | Active Comparator | The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. |
|
| Conventional angioplasty balloon catheters | Active Comparator | Commercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Device | The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Lesions Requiring Adjunctive Treatment | Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon | Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Kideny Disease & Hypertension Surgery Center | Phoenix | Arizona | 85012 | United States | ||
| The Vascular Experts |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Units | Lesions | Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour | Lesions | Lesions |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Femur Fracture after fall | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Restenosis or occlusion | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Saunders | Cook Research Incorporated | 765-463-7537 | Alan.Saunders@CookMedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2018 | Aug 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Conventional angioplasty balloon catheters | Device | Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula |
|
| Darien |
| Connecticut |
| 06820 |
| United States |
| Delaware Kidney/Nephrology Associates, PA | Newark | Delaware | 19713 | United States |
| Fairlawn Surgery Center | Roanoke | Virginia | 24014 | United States |
| Vascular Institute of Virginia | Woodbridge | Virginia | 22193 | United States |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 |
|
|
|
| 1 |
| 102 |
| 2 |
| 102 |
| 24 |
| 102 |
| EG001 | 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 | 2 | 109 | 1 | 109 | 23 | 109 |
| Diabetic ulcer of lower extremity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Head injury s/p fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Septic Shock | Infections and infestations | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |