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The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-Eluting Stent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zilver® PTX® Drug-Eluting Peripheral Stent | Device | Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Without Target Lesion Revascularization (TLR) | A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States | ||
| Stanford University Medical School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33025243 | Derived | Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6. |
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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 after final report has been distributed and ending 5 years after final report has been distributed. 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 | Drug-Eluting Stent | Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Stanford |
| California |
| 94305 |
| United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| The Cardiac and Vascular Institute | Gainesville | Florida | 32605 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32216 | United States |
| Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | United States |
| Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| New York-Presbyterian/ Weill Cornell Medical Center | New York | New York | 10065 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
| Holy Spirit Hospital | Camp Hill | Pennsylvania | 17011 | United States |
| South Carolina Heart Center | Columbia | South Carolina | 29204 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29615 | United States |
| Holston Valley Hospital | Kingsport | Tennessee | 37660 | United States |
| 12-Month Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug-Eluting Stent | Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. |
| 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 | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||||
| Smoking Status | Count of Participants | Participants |
| ||||||||||||||||||
| Hypercholesterolemia | Count of Participants | 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 | Patients Without Target Lesion Revascularization (TLR) | A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure. | The result was calculated using the Kaplan-Meier method (with Greenwood's formula for standard error). | Posted | Count of Participants | Participants | No | 1 year |
|
|
|
|
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 | Drug-Eluting Stent | Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. | 32 | 200 | 154 | 200 | 46 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Bandaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Femoral hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mesenteric arterial occlusion | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatic disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Physical deconditioning | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Stent-graft endoleak | General disorders | MedDRA | Systematic Assessment |
| |
| Vascular stent stenosis | General disorders | MedDRA | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic mass | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacterial colitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Emphysematous cholecystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Incision site cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vascular access site infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| West Nile viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arterial bypass occlusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arterial bypass stenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arterial bypass thrombosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arterial restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arteriovenous fistula site haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Cardiac valve rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Carotid artery restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Peripheral artery restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Postoperative respiratory distress | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vascular graft stenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Catheterisation cardiac abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA | Systematic Assessment |
| |
| Troponin | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung adenocarcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant respiratory tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Rectosigmoid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Device damage | Product Issues | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder mass | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Penis disorder | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Cough | 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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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Obliterative bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Ischaemic skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Debridement | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Dialysis device insertion | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Medical device battery replacement | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Medical device removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Mitral valve repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Rotator cuff repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Arterial stenosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Atheroembolism | 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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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypertensive emergency | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | MedDRA | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA | Systematic Assessment |
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| Ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral artery dissection | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral artery occlusion | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral artery thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral coldness | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral embolism | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
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| Peripheral vascular disorder | Vascular disorders | MedDRA | Systematic Assessment |
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| Steal syndrome | Vascular disorders | MedDRA | Systematic Assessment |
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| Subclavian artery stenosis | Vascular disorders | MedDRA | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral artery restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA | Systematic Assessment |
|
The sponsor can review results communications from PI prior to public release and can embargo communications of trial results between 60 and 180 days from the time submitted to the sponsor for review. The sponsor can embargo publications until the sponsor has published results or 180 days has elapsed after study closure at all participating sites. The sponsor cannot restrict publication but can require changes to protect sponsor's intellectual property rights or other confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Biostatistics | Cook Research Incorporated | 7654637537 | 321204 | Alan.Saunders@CookMedical.com |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Black/Caucasian or White |
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| Caucasian or White |
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| Hispanic or Latino |
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| Still smoking |
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