Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter: A Prospective, Randomized, Comparative Study

Conditions
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Deep Venous Thrombosis

Intervention / Treatment
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* Device: Infrarenal vena cava filter placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denali Group<br>Those who received Denali filter placement | Device: Infrarenal vena cava filter placement<br>* 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<br>|
| Experimental: Celect Group<br>Those who received Celect filter placement | Device: Infrarenal vena cava filter placement<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of penetration |  | 2 months after filter placement | 
| tilt angle |  | 2 months after filter placement | 
| Filter migration | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inferior vena cava, filter, deep venous thrombosis, pulmonary embolism, complex retrieval