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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Single arm

SafeFlo IVC Filter

Group Type EXPERIMENTAL

SafeFlo IVC Filter

Intervention Type DEVICE

SafeFlo IVC Filter

Interventions

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SafeFlo IVC Filter

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No