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| ID | Type | Description | Link |
|---|---|---|---|
| 110006, GTMX |
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| Name | Class |
|---|---|
| MED Institute, Incorporated | INDUSTRY |
| William Cook Australia | INDUSTRY |
| William Cook Europe | INDUSTRY |
| Cook Ireland, Ltd. |
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The clinical study will collect data to verify the safety and performance of the Cook Celect Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent high risk of thromboembolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Vena Cava Filter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celect Vena Cava Filter | Device | Effective filtration of inferior vena cava blood to prevent thromboembolism. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Event | Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Retrieval | Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R.W. Gunther, Prof. | Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Alfred Hospital | Melbourne | 3181 | Australia | |||
| RWTH Aachen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19875061 | Result | Lyon SM, Riojas GE, Uberoi R, Patel J, Lipp ME, Plant GR, De Gregorio MA, Gunther RW, Voorhees WD, McCann-Brown JA. Short- and long-term retrievability of the Celect vena cava filter: results from a multi-institutional registry. J Vasc Interv Radiol. 2009 Nov;20(11):1441-8. doi: 10.1016/j.jvir.2009.07.038. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Celect Vena Cava Filter |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Celect Vena Cava Filter |
| 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 | Major Adverse Event | Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture. | Posted | Number | participants | up to 12 months |
|
|
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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 | Celect Vena Cava Filter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage, Perforation | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Snyder | Cook | 765-463-7537 | ssnyder@medinst.com |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| INDUSTRY |
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| up to 12 months |
| Mean Time to Retrieval Attempt | Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made. A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made. | up to 12 months |
| Aachen |
| D-52057 |
| Germany |
| Instituto Nacional de Enfermedades Respiratorias | Mexico City | 14080 | Mexico |
| Hospital Universitario de Nuevo Leon | Monterrey | 64460 | Mexico |
| Universitario Zaragoza - Hospital Clinico | Zaragoza | 50009 | Spain |
| North Hampshire Hospital | Hampshire | RG24 9NA | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS97TF | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Cancer | Number | participants |
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| Coagulation Disorder | Number | participants |
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| Congestive Heart Failure (CHF) | Number | participants |
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| Coronary Heart Disease (CHD) | Number | participants |
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| Current Deep Venous Thrombosis (DVT) | Number | participants |
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| Current Pulmonary Embolism (PE) | Number | participants |
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| Diabetes | Number | participants |
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| Gastrointestinal (GI) Disease | Number | participants |
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| Hepatic Disease | Number | participants |
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| Hypertension | Number | participants |
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| Peripheral Vascular Disease (PVD) | Number | participants |
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| Pulmonary Disease | Number | participants |
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| Renal Disease | Number | participants |
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| Stroke | Number | participants |
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| Trauma | Number | participants |
|
|
| Secondary | Successful Retrieval | Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device). | 129 patients received a filter. Filters were placed as permanent devices in 34 patients and as temporary devices in 95 patients. A decision to retrieve a filter was made by the physician once the patient's medical condition warranted it (once the fliter was no longer required). Filter retrieval was attempted in 58 of 95 patients. | Posted | Number | successful retrievals | up to 12 months |
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|
|
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| Secondary | Mean Time to Retrieval Attempt | Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made. A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made. | Posted | Mean | Standard Deviation | days | up to 12 months |
|
|
|
| 3 |
| 129 |
| 0 |
| 129 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
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| Procedure or Device Related Death | Injury, poisoning and procedural complications | 1 death occured within 24 hours of device placement. Poor overall health likely contributed to death. 1 death occurred 185 days post-procedure and was the result of a pulmonary thromboembolism; the location of the origin of the clot was unknown. |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |