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

Study Overview
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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.

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

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: SafeFlo IVC Filter


Participation Criteria
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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: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>SafeFlo IVC Filter | Device: SafeFlo IVC Filter<br>* SafeFlo IVC Filter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |