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The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular | Experimental | Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents | Device | Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success Proportion | Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Farber, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham Hosptial | Birmingham | Alabama | 35233 | United States | ||
| St. Joseph's Hospital and Medical Center-Dignity Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endovascular | Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 17, 2020 |
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| Phoenix |
| Arizona |
| 85013 |
| United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90024 | United States |
| Kaiser Permanente | San Francisco | California | 94115 | United States |
| Stanford University Medical School | Stanford | California | 94305 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102-8000 | United States |
| Boca Raton Community Hospita | Boca Raton | Florida | 33486 | United States |
| Tampa General Hospital | Tampa | Florida | 33601 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Methodist Hospital of Indiana | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| Minneapolis Heart Inst. Foundation | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Barnes Jewish Hospital Plaza | St Louis | Missouri | 63110 | United States |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | United States |
| New York University - Langone Medical Center | New York | New York | 10016 | United States |
| Mount Sinai Roosevelt | New York | New York | 10025 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| UT Southwestern | Dallas | Texas | 75235 | United States |
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| The Methodist Hospital - Smith Tower | Houston | Texas | 77030 | United States |
| Baylor Scott and White Research Institute | Irving | Texas | 75061 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Started 6-Month |
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| Completed 6-Month |
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| Started 12-Month |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Endovascular | Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | One participant had an unreported race/ethnicity | Count of Participants | Participants |
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| 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 Proportion | Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications | Eight patients had incomplete outcome data either due to death, loss to follow-up, missed visits, or any combination thereof. | Posted | Number | 95% Confidence Interval | Proportion of participants | 12 months |
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1 year
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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 | Endovascular | Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert and guide the study device(s) into place in the aorta. | 4 | 80 | 25 | 80 | 8 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Asthenia | General disorders | MedDRA | Systematic Assessment |
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| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Stent-graft endoleak | General disorders | MedDRA | Systematic Assessment |
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| Vascular stent occlusion | General disorders | MedDRA | Systematic Assessment |
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| Vascular stent stenosis | General disorders | MedDRA | Systematic Assessment |
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| Vascular stent thrombosis | General disorders | MedDRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Renal artery occlusion | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Renal infarct | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Renal mass | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Debridement | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Peripheral artery aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Stent-graft endoleak | General disorders | MedDRA | 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 |
| Oct 3, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |
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| White(origins of Europe, Middle East, or North Africa) |
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