Pulmonary Embolism
Conditions
Keywords
increased risk for PE require caval interruption
Brief summary
This study is designed to evaluate the safety and efficacy of the RexMedical Option\* Vena Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and require caval interruption.
Interventions
DEVICEIntravascular Filter Device
Vena cava filter which is implanted into the inferior vena cava of patients to prevent recurrent pulmonary embolism. The filter can be utilized as a permanent or retrievable device.
Sponsors
Rex Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patient is at least 18 years of age * Patient requires temporary or permanent caval interruption Key
Exclusion criteria
* Patient has pre-existing filter implanted in her/her vasculature or has undergone filter retrieval within 60 days prior to study device implant * Patient is currently enrolled in another investigational device or drug trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Success | up to 180 days | Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition. |
| Percentage of Participants With Retrieval Clinical Success | upto 175 days | Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Placement Technical Success | Immediately post placement procedure | Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Option IVC Filter Device Placement All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Option IVC Filter Device Placement |
|---|---|
| Age Continuous | 59.1 years STANDARD_DEVIATION 16.7 |
| Age, Customized <18 years | 0 participants |
| Age, Customized >=18 years | 100 participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 73 / 100 |
| serious Total, serious adverse events | 65 / 100 |
Outcome results
Primary
Percentage of Participants With Clinical Success
Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.
Time frame: up to 180 days
Population: The number of participants was determined per intention to treat (ITT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Option IVC Filter Device Placement | Percentage of Participants With Clinical Success | 88 Percent of Participants |
Primary
Percentage of Participants With Retrieval Clinical Success
Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.
Time frame: upto 175 days
Population: The population for Option filter retrieval was based on intention to treat (ITT). Retrieval procedures were attempted in 39 of the 100 enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Option IVC Filter Device Placement | Percentage of Participants With Retrieval Clinical Success | 92 Percent of Participants |
Secondary
Placement Technical Success
Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism.
Time frame: Immediately post placement procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Option IVC Filter Device Placement | Placement Technical Success | 100 Percent of Participants |