Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter

Not Applicable

• Conditions: Deep Venous Thrombosis
• Interventions: Device: Infrarenal vena cava filter placement

• Registration Number: NCT03987321
• Lead Sponsor: Yonsei University

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)

Study Timeline

• Study First Submitted: 2019-05-26
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-13
• Last Update Submitted: 2019-06-13
• Study First Posted: 2019-06-17
• Last Update Posted: 2019-06-17
• Study Start: 2019-07
• Primary Completion: 2020-05
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celect Group	Infrarenal vena cava filter placement	Those who received Celect filter placement
Denali Group	Infrarenal vena cava filter placement	Those who received Denali filter placement

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of penetration	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.
tilt angle	2 months after filter placement
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.

Trial Locations

Locations (1)

Department of Radiology, Severance hospital, Yonsei College of Medicine; 🇰🇷 Seoul, Korea, Republic of