RexMedical- Option* Vena Cava Filter IDE Study

This study has been completed.
Sponsor:
Information provided by:
Rex Medical
ClinicalTrials.gov Identifier:
NCT00488865
First received: June 18, 2007
Last updated: August 4, 2010
Last verified: August 2010
  Purpose

This study is designed to evaluate the safety and efficacy of the RexMedical Option* Vena Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and require caval interruption.


Condition Intervention
Pulmonary Embolism
Device: Intravascular Filter Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: RexMedical- Option* Vena Cava Filter IDE Study

Resource links provided by NLM:


Further study details as provided by Rex Medical:

Primary Outcome Measures:
  • Percentage of Participants With Clinical Success [ Time Frame: up to 180 days ] [ Designated as safety issue: Yes ]
    Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.

  • Percentage of Participants With Retrieval Clinical Success [ Time Frame: upto 175 days ] [ Designated as safety issue: Yes ]
    Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.


Secondary Outcome Measures:
  • Placement Technical Success [ Time Frame: Immediately post placement procedure ] [ Designated as safety issue: Yes ]
    Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism.


Enrollment: 100
Study Start Date: October 2006
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intravascular Filter Device Device: Intravascular Filter Device
Vena cava filter which is implanted into the inferior vena cava of patients to prevent recurrent pulmonary embolism. The filter can be utilized as a permanent or retrievable device.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Patient is at least 18 years of age
  • Patient requires temporary or permanent caval interruption

Key Exclusion Criteria:

  • Patient has pre-existing filter implanted in her/her vasculature or has undergone filter retrieval within 60 days prior to study device implant
  • Patient is currently enrolled in another investigational device or drug trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488865

Locations
United States, California
Peninsula Surgical Specialists Medical Group, Inc.
Burlingame, California, United States, 94010
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19713
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Miami Cardiac & Vascular Institute
Miami, Florida, United States, 33176
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
New York Presbyterian Hospital/Columbia
New York, New York, United States, 10032
United States, Oregon
OHSU
Portland, Oregon, United States, 97201
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Rex Medical
  More Information

No publications provided by Rex Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lindsay Carter, Rex Medical
ClinicalTrials.gov Identifier: NCT00488865     History of Changes
Other Study ID Numbers: REX-US-2006-001
Study First Received: June 18, 2007
Results First Received: May 3, 2010
Last Updated: August 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Rex Medical:
increased risk for PE require caval interruption

Additional relevant MeSH terms:
Pulmonary Embolism
Lung Diseases
Respiratory Tract Diseases
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 02, 2014