Deep Venous Thrombosis
Conditions
Keywords
Inferior vena cava, filter, deep venous thrombosis, pulmonary embolism, complex retrieval
Brief summary
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.
Detailed description
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)
Interventions
DEVICEInfrarenal vena cava filter placement
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
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to the filter type.
Intervention model description
Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Patients who develop deep venous thrombosis and/or pulmonary embolism but are good candidates for anticoagulant therapy * 2\. Inferior vena cava filtration before mechanical thrombectomy for deep venous thrombosis * 3\. Prophylactic filter placement because of trauma or major surgery
Exclusion criteria
* 1\. Sepsis * 2\. Those who need permanent filter placement * 3\. Congenital anatomical anomaly (IVC duplication, interrupted IVC) * 4\. patients who need filter placement in the suprarenal inferior vena cava
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complicated filter retrieval | 2 months after filter placement | Incidence of retrieval cases that require the use of standard retrieval kit (sheath and snare) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of penetration | 2 months after filter placement | — |
| tilt angle | 2 months after filter placement | — |
| Filter migration | 2 months after filter placement | 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. |
| fracture | 2 months after filter placement | Filter fracture is any loss of a filter's structural integrity(ie, breakage or separation) documented by imaging. |
| signs of inferior vena cava occlusion/stenosis | 2 months after filter placement | Any signs of narrowing or obstruction of the IVC where the IVC filter was inserted as documented by CT. |
Countries
South Korea
Contacts
Primary ContactMan Deuk Kim
Outcome results
None listed