A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter

Completed · Not applicable

Conditions studied: Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT00654979

Run by

RMT Medical Technologies, Ltd.

People needed

117

Starts

2003-07-01

Expected to finish

2008-03-01

Last updated by the study team

2013-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• Holy Name Hospital — Teaneck, New Jersey, United States
• Mt. Sinai Hospital — Manhattan, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University Hospital Vienna — Vienna, Austria
• 251 Air Force Hospital — Athens, Greece
• Rabin Medical Center — Petah Tikva, Israel
• Universitas Hospital — Bloemfontein, South Africa
• Queen Margaret Hospital — Dumfermline, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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