RexMedical- Option* Vena Cava Filter IDE Study
- Conditions
- Pulmonary Embolism
- Interventions
- Device: Intravascular Filter Device
- Registration Number
- NCT00488865
- Lead Sponsor
- Rex Medical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Patient is at least 18 years of age
- Patient requires temporary or permanent caval interruption
Key
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intravascular Filter Device Intravascular Filter Device -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Clinical Success up to 180 days 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 upto 175 days Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.
- Secondary Outcome Measures
Name Time Method Placement Technical Success Immediately post placement procedure 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.
Trial Locations
- Locations (10)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Christiana Care Health System
🇺🇸Newark, Delaware, United States
New York Presbyterian Hospital/Columbia
🇺🇸New York, New York, United States
Peninsula Surgical Specialists Medical Group, Inc.
🇺🇸Burlingame, California, United States
OHSU
🇺🇸Portland, Oregon, United States
Miami Cardiac & Vascular Institute
🇺🇸Miami, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States