Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter

Deep Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03987321
• Other study ID #: 1-2019-0020
• Status: Recruiting
• Phase: N/A
• Start date: July 2019
• Est. completion date: June 2020

Study information

• Verified date: June 2019
• Source: Yonsei University
• Contact: Man Deuk Kim
• Phone: 82-2-2228-7400
• Email: mdkim[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Infrarenal 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

Locations

Country	Name	City	State
Korea, Republic of	Department of Radiology, Severance hospital, Yonsei College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of penetration		2 months after filter placement
Secondary	tilt angle		2 months after filter placement
Secondary	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
Secondary	fracture	Filter fracture is any loss of a filter's structural integrity(ie, breakage or separation) documented by imaging.	2 months after filter placement
Secondary	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