NCT00654979

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

4.7 years

First QC Date

March 30, 2008

Last Update Submit

May 30, 2013

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Single arm

EXPERIMENTAL

SafeFlo IVC Filter

Device: SafeFlo IVC Filter

Interventions

SafeFlo IVC FilterDEVICE

SafeFlo IVC Filter

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • +4 more criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Holy Name Hospital

Teaneck, New Jersey, United States

Location

Mt. Sinai Hospital

Manhattan, New York, United States

Location

Montefiore Medical Center

The Bronx, New York, United States

Location

University Hospital Vienna

Vienna, Austria

Location

251 Air Force Hospital

Athens, Greece

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Universitas Hospital

Bloemfontein, South Africa

Location

Queen Margaret Hospital

Dumfermline, Scotland, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Jacob Cynamon, Dr.

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 9, 2008

Study Start

July 1, 2003

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

GR(1)IL(1)AU(1)ZA(1)GB(1)US(3)