Pulmonary Embolism
Conditions
Brief summary
The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter
Interventions
DEVICEOPTEASE Vena Cava Filter
Sponsors
Cordis US Corp.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* · Pulmonary thromboembolism when anticoagulants are contraindicated. * Failure of anticoagulant therapy in thromboembolic diseases. * Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced. * Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
Exclusion criteria
* · Patients with risk of septic embolism. * Patients with uncontrolled infectious disease. * Patients with an IVC diameter \> 30 mm. * Patients contraindicated for procedures under fluoroscopy. * Patients with demonstrated hypersensitivity to one or more of the components of the OptEase™ filter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary endpoints are migration of the OptEase™ IVC filter as determined by abdominal x-ray at 1-month post-implantation and symptomatic thrombosis at 1-month post-implantation. Migration is defined as > 2 cm movement in either cranial or caudal | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the longer-term stability of the filter defined by the lack of migration as seen on abdominal x-ray at 6-month post-implantation. Migration is defined as > 2 cm movement in either cranial or caudal direction as seen on abdominal x-ray compar | — |
| To assess the clinical success of the filter up to 6-month follow-up. Clinical success is defined as the absence of symptomatic pulmonary embolism (PE) evaluated clinically at post-implantation, 1- and 6-months post-implantation. | — |
| To assess the technical success of the filter up to 6-month follow-up. Technical success is defined as the filter successfully deployed at the intended site in the IVC with the correct orientation. | — |
| To assess major adverse event rates related to the filter or filter procedure, up to 6-month follow-up, in aggregate and individually. Major adverse events are defined as 1) death, 2) pulmonary embolism, 3) symptomatic thrombosis, 4) caval penetration | — |
| To assess filter fracture up to 6-month follow-up. | — |
| Procedure-related bleeding (defined as requiring transfusion or > 3 gm decrease in hemoglobin). | — |
| To assess significant tilting (> 15° off the axis of the IVC) up to 6-month follow-up. | — |
Outcome results
None listed