Clinical trial NCT00233740: Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)
Official title: The Cordis Protection From Pulmonary Embolism With the Permanent OptEase™ Filter - A Post Marketing Surveillance Study (PROOF Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Embolism
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: 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
measure: 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
measure: 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.
measure: 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.
measure: To assess significant tilting (> 15° off the axis of the IVC) up to 6-month follow-up.
measure: To assess filter fracture up to 6-month follow-up.
measure: Procedure-related bleeding (defined as requiring transfusion or > 3 gm decrease in hemoglobin).
Other outcomes:
Locations:
Study officials:
affiliation: Sunrise Hospital and Medical Center
name: Peter Weidenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziegler JW, Dietrich GJ, Cohen SA, Sterling K, Duncan J, Samotowka M. PROOF trial: protection from pulmonary embolism with the OptEase filter. J Vasc Interv Radiol. 2008 Aug;19(8):1165-70. doi: 10.1016/j.jvir.2008.04.020. Epub 2008 Jun 27.