Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE
Brief summary
The clinical study will collect data to verify the safety and performance of the Cook Celect Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent high risk of thromboembolism.
Interventions
DEVICECelect Vena Cava Filter
Effective filtration of inferior vena cava blood to prevent thromboembolism.
Sponsors
MED Institute, Incorporated
William Cook Australia
William Cook Europe
Cook Ireland, Ltd.
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient is at high risk for pulmonary embolism and is under consideration for placement of a permanent or short-term IVC filter. * The patient must have a patent internal jugular vein. * The patient or guardian must have given informed consent. * The patient must agree to return for clinical imaging follow-up at 1, 3, 6, and 12 months. * The patient must agree to have a clinical and imaging examination performed prior to filter retrieval. * The patient must agree to return for clinical and imaging follow-up at 30 days and 3 months after filter retrieval.
Exclusion criteria
* The patient is less than 18 years of age. * The patient is pregnant. * The patient has uncontrollable coagulopathy. * The patient has a life expectancy less than 6 months. * The patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters. * The patient's vena cava diameter is less than 15 mm, measured by vena cava sizing catheters. * The patient has a contrast allergy that can not be adequately pre-medicated. * The patient is simultaneously participating in another investigative drug or device study, or has a previous IVC filter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Event | up to 12 months | Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Retrieval | up to 12 months | Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device). |
| Mean Time to Retrieval Attempt | up to 12 months | Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made. A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made. |
Countries
Australia, Germany, Mexico, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celect Vena Cava Filter | 129 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Celect Vena Cava Filter |
|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 19 |
| Cancer Cancer | 23 participants |
| Cancer No Cancer | 106 participants |
| Coagulation Disorder Coagulation Disorder | 4 participants |
| Coagulation Disorder No Coagulation Disorder | 125 participants |
| Congestive Heart Failure (CHF) CHF | 1 participants |
| Congestive Heart Failure (CHF) No CHF | 128 participants |
| Coronary Heart Disease (CHD) CHD | 1 participants |
| Coronary Heart Disease (CHD) No CHD | 128 participants |
| Current Deep Venous Thrombosis (DVT) Current DVT | 72 participants |
| Current Deep Venous Thrombosis (DVT) No Current DVT | 57 participants |
| Current Pulmonary Embolism (PE) Current PE | 50 participants |
| Current Pulmonary Embolism (PE) No Current PE | 79 participants |
| Diabetes Diabetes Type I | 2 participants |
| Diabetes Diabetes Type II | 10 participants |
| Diabetes No Diabetes | 117 participants |
| Gastrointestinal (GI) Disease GI Disease | 8 participants |
| Gastrointestinal (GI) Disease No GI Disease | 121 participants |
| Hepatic Disease Hepatic Disease | 3 participants |
| Hepatic Disease No Hepatic Disease | 126 participants |
| Hypertension Hypertension | 0 participants |
| Hypertension No Hypertension | 129 participants |
| Peripheral Vascular Disease (PVD) No PVD | 122 participants |
| Peripheral Vascular Disease (PVD) PVD | 7 participants |
| Pulmonary Disease No Pulmonary Disease | 96 participants |
| Pulmonary Disease Pulmonary Disease | 33 participants |
| Renal Disease No Renal Disease | 124 participants |
| Renal Disease Renal Disease | 5 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 71 Participants |
| Stroke No Stroke | 122 participants |
| Stroke Stroke | 7 participants |
| Trauma No Trauma | 91 participants |
| Trauma Trauma | 38 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 129 |
| serious Total, serious adverse events | 3 / 129 |
Outcome results
Primary
Major Adverse Event
Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.
Time frame: up to 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celect Vena Cava Filter | Major Adverse Event | Hemorrhage, Perforation | 0 participants |
| Celect Vena Cava Filter | Major Adverse Event | Pulmonary Embolism | 1 participants |
| Celect Vena Cava Filter | Major Adverse Event | Procedure or Device-Related Death | 2 participants |
| Celect Vena Cava Filter | Major Adverse Event | Inferior Vena Cava Occlusion | 0 participants |
| Celect Vena Cava Filter | Major Adverse Event | Significant Migration | 0 participants |
| Celect Vena Cava Filter | Major Adverse Event | Filter Fracture | 0 participants |
Secondary
Mean Time to Retrieval Attempt
Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made. A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made.
Time frame: up to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celect Vena Cava Filter | Mean Time to Retrieval Attempt | 186 days | Standard Deviation 124 |
Secondary
Successful Retrieval
Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device).
Time frame: up to 12 months
Population: 129 patients received a filter. Filters were placed as permanent devices in 34 patients and as temporary devices in 95 patients. A decision to retrieve a filter was made by the physician once the patient's medical condition warranted it (once the fliter was no longer required). Filter retrieval was attempted in 58 of 95 patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celect Vena Cava Filter | Successful Retrieval | 56 successful retrievals |