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| Sponsor: | RMT Medical Technologies, Ltd. |
|---|---|
| Information provided by: | RMT Medical Technologies, Ltd. |
| ClinicalTrials.gov Identifier: | NCT00654979 |
Purpose
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 |
|---|---|
|
Pulmonary Embolism |
Device: SafeFlo IVC Filter |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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) |
Eligibility| 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:
Contacts and Locations| 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 | |
| Queen Margaret Hospital | |
| Dumfermline, Scotland, United Kingdom | |
More Information
| Responsible Party: | Aaron Feldman, CEO, RMT Medical Technologies, Ltd. |
| ClinicalTrials.gov Identifier: | NCT00654979 History of Changes |
| Other Study ID Numbers: | SFF-104 |
| Study First Received: | March 30, 2008 |
| Last Updated: | April 3, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Embolism Pulmonary Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |