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The primary purpose of this study is to compare the Celect and Denali filters in terms of complicated filter retrieval and indwelling complications after a 2-month indwelling time.
With anticoagulation being the standard treatment for deep venous thrombosis and pulmonary embolism, inferior vena cava filter placement plays an important role in patients who are amenable to anticoagulant therapy. Currently, many different types of retrievable filters are being used in clinical practice and the choice of the filters depends on operators' preference and institutional availability. Each filter has different designs to maximize retrievability and minimize indwelling complications. Up until now, the prior studies on the filter retrievability and indwelling complications have been retrospective in nature and had relatively long dwell times. Comparative data regarding the retrievability of the inferior vena cava filters may help to choose filter selection. Therefore, the aim of this trial is to compare two commonly used inferior vena cava filters (Denali and Celet filters)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denali Group | Experimental | Those who received Denali filter placement |
|
| Celect Group | Experimental | Those who received Celect filter placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infrarenal vena cava filter placement | Device | Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava. All other procedures are the same in both groups |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complicated filter retrieval | Incidence of retrieval cases that require the use of standard retrieval kit (sheath and snare) | 2 months after filter placement |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of penetration | 2 months after filter placement | |
| tilt angle | 2 months after filter placement | |
| Filter migration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Man Deuk Kim | Contact | 82-2-2228-7400 | mdkim@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiology, Severance hospital, Yonsei College of Medicine | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava.
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Participants are blinded to the filter type.
Filter migration is a change in filter position com-pared with its deployed position (cranial or caudal) of more than 2 cm as documented by diagnostic imaging. |
| 2 months after filter placement |
| fracture | Filter fracture is any loss of a filter's structural integrity(ie, breakage or separation) documented by imaging. | 2 months after filter placement |
| signs of inferior vena cava occlusion/stenosis | Any signs of narrowing or obstruction of the IVC where the IVC filter was inserted as documented by CT. | 2 months after filter placement |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |