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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RMT Medical Technologies, Ltd.
ClinicalTrials.gov Identifier:
NCT00654979
First received: March 30, 2008
Last updated: May 30, 2013
Last verified: May 2013
  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

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: 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: May 30, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 18, 2014