Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter

NCT ID: NCT03987321

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2020-06-30

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)

Conditions

Deep Venous Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Denali Group

Those who received Denali filter placement

Group Type: EXPERIMENTAL

Infrarenal vena cava filter placement

Intervention Type: DEVICE

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

Celect Group

Those who received Celect filter placement

Group Type: EXPERIMENTAL

Infrarenal vena cava filter placement

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Radiology, Severance hospital, Yonsei College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Man Deuk Kim

Role: CONTACT

mdkim@yuhs.ac

82-2-2228-7400

Facility Contacts

Man Deuk Kim, MD, Ph.D

Role: primary

mdkim@yuhs.ac

82-2-2228-7400

Other Identifiers

1-2019-0020

Identifier Type: -

Identifier Source: org_study_id