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

Not Applicable

Completed

• Conditions: Pulmonary Embolism
• Interventions: Device: SafeFlo IVC Filter

• Registration Number: NCT00654979
• Lead Sponsor: RMT Medical Technologies, Ltd.

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

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-03-30
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	SafeFlo IVC Filter	SafeFlo IVC Filter

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (8)

Queen Margaret Hospital; 🇬🇧 Dumfermline, Scotland, United Kingdom

Universitas Hospital; 🇿🇦 Bloemfontein, South Africa

University Hospital Vienna; 🇦🇹 Vienna, Austria

Mt. Sinai Hospital; 🇺🇸 Manhattan, New York, United States

251 Air Force Hospital; 🇬🇷 Athens, Greece

Holy Name Hospital; 🇺🇸 Teaneck, New Jersey, United States

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States