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The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zenith® Branch Endovascular Graft-Iliac Bifurcation | Experimental | Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenith® Branch Endovascular Graft-Iliac Bifurcation, | Device | Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Morbidity (i.e., Morbidity Index) | Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular). | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W. Anthony Lee, MD FACS | Christine E. Lynn Heart and Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Foundation for Medical Education and Research | Phoenix | Arizona | 85054 | United States | ||
| VA Palo Alto HCS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41067585 | Derived | Lee WA, Mantese V, Lee JT, Long G, Cable D, Hu M. Five-year outcomes of the PRESERVE II Zenith iliac branch pivotal clinical study. J Vasc Surg. 2026 Feb;83(2):413-421.e2. doi: 10.1016/j.jvs.2025.09.052. Epub 2025 Oct 9. |
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Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zenith® Branch Endovascular Graft-Iliac Bifurcation | Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation. Atrium iCAST™: Implantation of Atrium iCAST Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft |
| 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 | Yes | No | No | Study Protocol | May 9, 2018 | Apr 14, 2025 |
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| Atrium iCASTâ„¢ | Device | Implantation of Atrium iCAST |
|
| Zenith® Flex AAA Endovascular Graft | Device | Implantation of the Zenith Flex Endovascular Graft |
|
| Palo Alto |
| California |
| 94304 |
| United States |
| Stanford University Medical School | Stanford | California | 94305 | United States |
| Christine E. Lynn Heart and Vascular Institute | Boca Raton | Florida | 33431 | United States |
| South Florida Medical Imaging | Fort Lauderdale | Florida | 33308 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| St. Anthony's Medical Center | Rockford | Illinois | 61108 | United States |
| Methodist Hospital of Indiana | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky Hospital | Lexington | Kentucky | 40536 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mercy Hospital East Communities | St Louis | Missouri | 63141 | United States |
| University of Nebraska | Omaha | Nebraska | 68105 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| UT Southwestern | Dallas | Texas | 75235 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Aurora St. Luke's Hospital | Milwaukee | Wisconsin | 53215 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zenith® Branch Endovascular Graft-Iliac Bifurcation | Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation. Atrium iCAST™: Implantation of Atrium iCAST Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft |
| 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, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | 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 | Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms. | One patient died prior to the 6-month visit and thus did not contribute data to the primary outcome. This death was related to a pre-existing condition. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Freedom From Morbidity (i.e., Morbidity Index) | Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular). | Posted | Count of Participants | Participants | 30 days |
|
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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® Branch Endovascular Graft-Iliac Bifurcation | Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation. Atrium iCAST™: Implantation of Atrium iCAST Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft | 4 | 40 | 26 | 40 | 15 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Chest pain | General disorders | MedDRA | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Stent-graft endoleak | 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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| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Vascular graft infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Central cord syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Ammonia increased | Investigations | MedDRA | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
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| Troponin I increased | Investigations | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Muscle necrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Thyroid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
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| Intraventricular haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Neurogenic bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Renal artery stenosis | 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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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hip arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
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| Arterial thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral artery aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
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| Arterial thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Saunders, MS, Senior Manager, Biostatistics | Cook Research Incorporated | 765-463-7537 | 321204 | alan.saunders@cookmedical.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D017543 | Iliac Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Hispanic or Latino |
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| White |
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