Pulmonary Embolism Clinical Trial
Official title:
RexMedical- Option* Vena Cava Filter IDE Study
Verified date | August 2010 |
Source | Rex Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Peninsula Surgical Specialists Medical Group, Inc. | Burlingame | California |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Indiana University School of Medicine | Indianapolis | Indiana |
United States | Miami Cardiac & Vascular Institute | Miami | Florida |
United States | New York Presbyterian Hospital/Columbia | New York | New York |
United States | Christiana Care Health System | Newark | Delaware |
United States | OHSU | Portland | Oregon |
United States | George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Rex Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Clinical Success | 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. | up to 180 days | Yes |
Primary | Percentage of Participants With Retrieval Clinical Success | Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention. | upto 175 days | Yes |
Secondary | Placement Technical Success | 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. | Immediately post placement procedure | Yes |
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