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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654979
• Other study ID #: SFF-104
• Status: Completed
• Phase: N/A
• First received: March 30, 2008
• Last updated: May 30, 2013
• Start date: July 2003
• Est. completion date: March 2008

Study information

• Verified date: May 2013
• Source: RMT Medical Technologies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pulmonary Embolism

Intervention

Device:
• SafeFlo IVC Filter
SafeFlo IVC Filter

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
RMT Medical Technologies, Ltd.

Countries where clinical trial is conducted

United States,  Austria,  Greece,  Israel,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   Sponsor Website