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Sponsored by: |
RMT Medical Technologies, Ltd. |
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Information provided by: | RMT Medical Technologies, Ltd. |
ClinicalTrials.gov Identifier: | NCT00654979 |
To determine the safety and effectiveness of the SafeFlo filter for permanent protection against pulmonary emboli. All patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. Patients with a permanent implantation will be followed for up to 6 months. Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of permanent filter patients considered to be a clinical success will be the primary efficacy parameter.
Condition | Intervention |
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Pulmonary Embolism |
Device: SafeFlo IVC Filter |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter |
Enrollment: | 117 |
Study Start Date: | July 2003 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Traditional indications for vena cava filter in patients with established DVT or PE, including (40):
Patients with proven Pulmonary Embolus (PE) or Deep Vein Thrombosis (DVT) and one or more of the following:
Failure of anticoagulation
Extended indications for vena cava filter placement in patients with established DVT or PE, including the following (31, 40):
High risk trauma or orthopedic patients who cannot receive anticoagulation because of increased bleeding risk, and have one or more of the following injury patterns (31, 40):
Exclusion Criteria:
United States, New Jersey | |
Holy Name Hospital | |
Teaneck, New Jersey, United States | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States | |
Mt. Sinai Hospital | |
Manhattan, New York, United States | |
Austria | |
University Hospital Vienna | |
Vienna, Austria | |
Greece | |
251 Air Force Hospital | |
Athens, Greece | |
Israel | |
Rabin Medical Center | |
Petach Tikva, Israel | |
South Africa | |
Universitas Hospital | |
Bloemfontein, South Africa | |
United Kingdom, Scotland | |
Queen Margaret Hospital | |
Dumfermline, Scotland, United Kingdom |
Responsible Party: | RMT Medical Technologies, Ltd. ( Aaron Feldman, CEO ) |
Study ID Numbers: | SFF-104 |
Study First Received: | March 30, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00654979 |
Health Authority: | United States: Food and Drug Administration |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism |
Lung Diseases Vascular Diseases Thrombosis |
Cardiovascular Diseases |