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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular Filter Device | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular Filter Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 180 days |
| 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. | upto 175 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately post placement procedure |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peninsula Surgical Specialists Medical Group, Inc. | Burlingame | California | 94010 | United States | ||
| Christiana Care Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20598570 | Derived | Johnson MS, Nemcek AA Jr, Benenati JF, Baumann DS, Dolmatch BL, Kaufman JA, Garcia MJ, Stecker MS, Venbrux AC, Haskal ZJ, Avelar RL. The safety and effectiveness of the retrievable option inferior vena cava filter: a United States prospective multicenter clinical study. J Vasc Interv Radiol. 2010 Aug;21(8):1173-84. doi: 10.1016/j.jvir.2010.04.004. Epub 2010 Jul 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Option IVC Filter Device Placement | All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Option IVC Filter Device Placement | All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants was determined per intention to treat (ITT). | Posted | Number | 95% Confidence Interval | Percent of Participants | up to 180 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Option IVC Filter Device Placement | All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device/Procedure Related SAE | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device/Procedure Related AE | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Bressler | Rex Medical | 610-940-0665 | ebressler@rexmedical.com |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| Newark |
| Delaware |
| 19713 |
| United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Miami Cardiac & Vascular Institute | Miami | Florida | 33176 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| New York Presbyterian Hospital/Columbia | New York | New York | 10032 | United States |
| OHSU | Portland | Oregon | 97201 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Posted | Number | 95% Confidence Interval | Percent of Participants | Immediately post placement procedure |
|
|
|
| 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. | The population for Option filter retrieval was based on intention to treat (ITT). Retrieval procedures were attempted in 39 of the 100 enrolled patients. | Posted | Number | 95% Confidence Interval | Percent of Participants | upto 175 days |
|
|
|
| 65 |
| 100 |
| 73 |
| 100 |
| Non Device/Procedure Related SAE | General disorders |
|
| Non Device/Procedure Related AE | General disorders |
|
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |