Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter

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

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.

Study Overview

• Status: Unknown
• Conditions: Deep Venous Thrombosis
• Intervention / Treatment: Device: Infrarenal vena cava filter placement

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 Type: Interventional
• Enrollment (Anticipated): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Radiology, Severance hospital, Yonsei College of Medicine
    • Contact: Man Deuk Kim, MD, Ph.D; Phone Number: 82-2-2228-7400; Email: mdkim@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Denali Group; Those who received Denali filter placement	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
EXPERIMENTAL: Celect Group; Those who received Celect filter placement	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: May 26, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: pulmonary embolism; deep venous thrombosis; Inferior vena cava; filter; complex retrieval
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 1-2019-0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No