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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SafeFlo IVC Filter
Sponsored by
RMT Medical Technologies, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Holy Name Hospital
  • Montefiore Medical Center
  • Mt. Sinai Hospital
  • University Hospital Vienna
  • 251 Air Force Hospital
  • Rabin Medical Center
  • Universitas Hospital
  • Queen Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

SafeFlo IVC Filter

Outcomes

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.

Secondary Outcome Measures

The proportion of patients with successful deployment of the filter will be calculated and presented with a 95% exact confidence interval.

Full Information

First Posted
March 30, 2008
Last Updated
May 30, 2013
Sponsor
RMT Medical Technologies, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00654979
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RMT Medical Technologies, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
SafeFlo IVC Filter
Intervention Type
Device
Intervention Name(s)
SafeFlo IVC Filter
Intervention Description
SafeFlo IVC Filter
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Contraindication to anticoagulation Complication of anticoagulation Failure of anticoagulation Recurrent PE despite adequate anticoagulation therapy Inability to achieve adequate anticoagulation 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): Severe closed head injury (GCS < 8); Incomplete spinal cord injury with para or quadriplegia; Complex pelvic fractures with associated long-bone fractures; 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Cynamon, Dr.
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
Country
United States
Facility Name
Mt. Sinai Hospital
City
Manhattan
State/Province
New York
Country
United States
Facility Name
University Hospital Vienna
City
Vienna
Country
Austria
Facility Name
251 Air Force Hospital
City
Athens
Country
Greece
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Facility Name
Universitas Hospital
City
Bloemfontein
Country
South Africa
Facility Name
Queen Margaret Hospital
City
Dumfermline
State/Province
Scotland
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.rafaelmedical.com
Description
Sponsor Website

Learn more about this trial

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

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