RexMedical- Option* Vena Cava Filter IDE Study
This study has been completed.
Sponsor:
Rex Medical
Information provided by:
Rex Medical
ClinicalTrials.gov Identifier:
NCT00488865
First received: June 18, 2007
Last updated: August 4, 2010
Last verified: August 2010
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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
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:
|
Embolism Pulmonary Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013