Status:
COMPLETED
A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter
Lead Sponsor:
RMT Medical Technologies, Ltd.
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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:
- Contraindication to anticoagulation
- Complication of anticoagulation
- Failure of anticoagulation
- Recurrent PE despite adequate anticoagulation therapy
- Inability to achieve adequate anticoagulation
- Poor compliance with anticoagulation medications
- Extended indications for vena cava filter placement in patients with established DVT or PE, including the following (31, 40):
- Large free-floating thrombus in the iliac vein or IVC;
- Following massive PE in which recurrent emboli may prove fatal;
- During/after surgical or transcatheter embolectomy;
- Filter placement in high-risk trauma and orthopedic patients:
- 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):
- Severe closed head injury (GCS \< 8);
- Incomplete spinal cord injury with para or quadriplegia;
- Complex pelvic fractures with associated long-bone fractures;
- Multiple long bone fractures.
- Patients undergoing long-term immobilization (e.g., ICU or Surgical oncology)
Exclusion
- All patients under 18 years of age.
- All patients undergoing emergency procedures.
- All patients with abnormal IVC anatomy or pathology of the IVC such as thrombosis or tumor which prevent safe filter implantation.
- All patients with an IVC diameter which precludes oversizing of the filter platform.
- All patients with active infection / bacteremia.
- All patients with sensitivity to contrast media.
- Uncorrectable severe coagulopathy (e.g., patients with liver or multisystem failure).
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00654979
Start Date
July 1 2003
End Date
March 1 2008
Last Update
May 31 2013
Active Locations (8)
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1
Holy Name Hospital
Teaneck, New Jersey, United States
2
Mt. Sinai Hospital
Manhattan, New York, United States
3
Montefiore Medical Center
The Bronx, New York, United States
4
University Hospital Vienna
Vienna, Austria