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Cook IVC Filter Study

NCT02046096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2022-01-20

Study results available
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Summary

This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).

Conditions

Interventions

DEVICE

Günther Tulip® Vena Cava Filter

Temporary or permanent filter placement for the prevention of pulmonary embolism

DEVICE

Cook Celect® Vena Cava Filters

Temporary or permanent filter placement for the prevention of pulmonary embolism

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Principal Investigators

  • H. Bob Smouse, MD · OSF St. Francis/Peoria Radiology Research and Education Foundation

  • Robert Feezor, MD · University of Florida Health-Shands

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-12-18
Completion
2019-08-09
FDA Device
Yes

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02046096 on ClinicalTrials.gov