Retrievability and Incidence of Complex Retrieval in Celect Versus Denali Filter

NCT03987321 | Unknown

• 1 other identifier: 1-2019-0020
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Venous Thrombosis

Keywords

Inferior vena cava; filter; deep venous thrombosis; pulmonary embolism; complex retrieval

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of penetration

  2 months after filter placement

• tilt angle

  2 months after filter placement

• Filter migration

  2 months after filter placement

• fracture

  2 months after filter placement

• signs of inferior vena cava occlusion/stenosis

  2 months after filter placement

Study Arms (2)

Denali Group

EXPERIMENTAL

Those who received Denali filter placement

Device: Infrarenal vena cava filter placement

Celect Group

EXPERIMENTAL

Those who received Celect filter placement

Device: Infrarenal vena cava filter placement

Interventions

Infrarenal vena cava filter placement 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; Denali Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients who develop deep venous thrombosis and/or pulmonary embolism but are good candidates for anticoagulant therapy
• \. Inferior vena cava filtration before mechanical thrombectomy for deep venous thrombosis
• \. Prophylactic filter placement because of trauma or major surgery

You may not qualify if:

• \. Sepsis
• \. Those who need permanent filter placement
• \. Congenital anatomical anomaly (IVC duplication, interrupted IVC)
• \. patients who need filter placement in the suprarenal inferior vena cava

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Radiology, Severance hospital, Yonsei College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Central Study Contacts

Man Deuk Kim

CONTACT

82-2-2228-7400; mdkim@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the filter type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava.

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: June 17, 2019
• Study Start: July 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)