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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: SafeFlo IVC Filter

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; SafeFlo IVC Filter	Device: SafeFlo IVC Filter; SafeFlo IVC Filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization.	6 months follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with successful deployment of the filter will be calculated and presented with a 95% exact confidence interval.	3 and 6 months follow-up

Collaborators and Investigators

• Sponsor: RMT Medical Technologies, Ltd.
• Investigators: Principal Investigator: Jacob Cynamon, Dr., Montefiore Medical Center

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: March 30, 2008
• First Submitted That Met QC Criteria: April 3, 2008
• First Posted (Estimate): April 9, 2008

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: SFF-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No