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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00654979
First Posted: April 9, 2008
Last Update Posted: May 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
RMT Medical Technologies, Ltd.
  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: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by RMT Medical Technologies, Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 117
Study Start Date: July 2003
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
SafeFlo IVC Filter
Device: SafeFlo IVC Filter
SafeFlo IVC Filter

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654979


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
Sponsors and Collaborators
RMT Medical Technologies, Ltd.
Investigators
Principal Investigator: Jacob Cynamon, Dr. Montefiore Medical Center
  More Information

Additional Information:
Responsible Party: RMT Medical Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT00654979     History of Changes
Other Study ID Numbers: SFF-104
First Submitted: March 30, 2008
First Posted: April 9, 2008
Last Update Posted: May 31, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases


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