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This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zenith® Fenestrated AAA Endovascular Graft | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenith® Fenestrated AAA Endovascular Graft | Device | The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success : AAA Related Mortality | patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% , | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-Davis | Sacramento | California | 95817 | United States | ||
| University of Colorado |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zenith® Fenestrated AAA Endovascular Graft | Zenith® Fenestrated AAA Endovascular Graft: The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zenith® Fenestrated AAA Endovascular Graft | The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg. Additional ancillary components (main body extensions, iliac leg extensions, converters, and occluders) are available. The Zenith® Alignment Stent is a balloon-expandable stent that can be deployed through scallops or fenestrations in a Zenith® Fenestrated AAA Endovascular Graft into branch vessels of the aorta. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Treatment Success : AAA Related Mortality | patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% , | patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair | Posted | Count of Participants | Participants | 5 years |
|
5 years
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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 | Zenith® Fenestrated AAA Endovascular Graft | The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Saunders, MS, RAC; Manager, Biostatistics | Cook Research Incorporated | 765-463-7537 | 321204 | alan.saunders@cookmedical.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2018 | Aug 17, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| D001014 | Aortic Aneurysm |
| D017543 | Iliac Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Wake Forest University Health | Winston-Salem | North Carolina | 27102 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53711 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 3 |
| 21 |
| 11 |
| 21 |
| 13 |
| 21 |
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | Systematic Assessment |
|
| Stent-graft endoleak | General disorders | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | Systematic Assessment |
|
| Gallbladder mass | Hepatobiliary disorders | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | Systematic Assessment |
|
| Dialysis | Surgical and medical procedures | Systematic Assessment |
|
| Transfusion | Surgical and medical procedures | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | Systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Stent-graft endoleak | General disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Transfusion | Surgical and medical procedures | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | Systematic Assessment |
|
| Renal infarct | Renal and urinary disorders | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | Systematic Assessment |
|
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