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

This study is ongoing, but not recruiting participants.
Study NCT00654979.   Last updated on April 3, 2008.   Information provided by RMT Medical Technologies, Ltd.

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Descriptive Information Fields
Brief Title  A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter
Official Title  A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter
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 / 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.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Prevention, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. [ Time Frame: 6 months follow-up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  The proportion of patients with successful deployment of the filter will be calculated and presented with a 95% exact confidence interval. [ Time Frame: 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
Condition  Pulmonary Embolism
Intervention  Device: SafeFlo IVC Filter
MEDLINE PMIDs
Links Sponsor Website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  117
Start Date  July 2003
Completion Date
Eligibility Criteria 

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:

      1. Contraindication to anticoagulation
      2. Complication of anticoagulation
      3. Failure of anticoagulation

        • Recurrent PE despite adequate anticoagulation therapy
        • Inability to achieve adequate anticoagulation
      4. 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):

    1. Severe closed head injury (GCS < 8);
    2. Incomplete spinal cord injury with para or quadriplegia;
    3. Complex pelvic fractures with associated long-bone fractures;
    4. Multiple long bone fractures.
  • Patients undergoing long-term immobilization (e.g., ICU or Surgical oncology)

Exclusion Criteria:

  • 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).
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Austria,   Greece,   Israel,   South Africa,   United Kingdom
Administrative Information Fields
NCT ID  NCT00654979
Organization ID SFF-104
Secondary IDs ††
Study Sponsor  RMT Medical Technologies, Ltd.
Collaborators ††
Investigators 
Information Provided By RMT Medical Technologies, Ltd.
Verification Date April 2008
First Received Date  March 30, 2008
Last Updated Date April 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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