Clinical trial NCT01120509: Crux Biomedical Vena Cava Filter Study - United States
Official title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Embolism
Keywords: Vena Cava
Vena Cava Filter
Pulmonary Embolism
Venous Thromboembolism
Risk of Pulmonary Embolism
Lead sponsor: Crux Biomedical
Sponsor class: INDUSTRY
First posted: 2010-05-11
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* Patient has a permanent or temporary risk of Pulmonary Embolism
* Patient or legal guardian must provide written informed consent
* At least one of the following conditions

  * Proven PE
  * Recurrent PE despite adequate anticoagulation
  * Contraindication to anticoagulation
  * Inability to achieve/maintain therapeutic anticoagulation
  * Iliocaval DVT
  * Large, free-floating proximal DVT
  * Massive PE treated with thrombolysis/thrombectomy
  * Chronic PE treated with thrombectomy
  * Procetion during thrombolysis for iliocaval DVT
  * PE with limited cardiopulmonary reserve
  * Poor compliance with anticoagulation medication
  * High risk of injury worsend by anticoagulation
  * Multi-trauma patient with high risk of PE
  * Surgical patients at high risk of PE
  * Medical condition with high risk of PE
* Patient has documented vena cava diameter of 17-28mm
* Patient has IVC anatomy suitable for infra-renal placement
* Patient willing to be available for the appropriate follow up.

Exclusion Criteria:

* Age \<18 years old
* Patient has any one of the following conditions

  * Renal vein thrombosis
  * IVC thrombosis extending to te renal veins
  * Duplicate IVC
  * Gonadal vein thrombosis
  * Requires supra-renal placement
* Uncontrolled infectious disease
* Risk of aseptic PE
* Uncontrolled coagulopathy
* Existing inferior vena cava filter implant
* Life expectancy less than 6 months
* Pregnant or planning a pregnancy in the next 6 months
* Condition that inhibits radiographic visualization of the IVC
* Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
* Known hypersensitivity to contract which cannot be pretreated
* Access vessels preclude safe insertion of delivery system
* Participation in another drug or device trial
* Unable or unwilling to cooperate with study procedures or required follow-up visits

Primary outcomes:
measure: Clinical Success
timeFrame: 6 Months
Secondary outcomes:
measure: Retrieval Success
timeFrame: 6 Months
measure: Filter Migration
timeFrame: 6 Months
measure: VCF Thrombus
timeFrame: 6 Months
measure: Device Integrity
timeFrame: 6 Months
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph's Hospital
state: California
city: Orange
country: United States
facility: University of California at Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: Univeristy of California at Davis Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Gainesville
country: United States
facility: University of Florida Medical Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Medical Center
state: Georgia
city: Augusta
country: United States
facility: University Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Peoria
country: United States
facility: St. Francis Hospital
state: Illinois
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Syracuse
country: United States
facility: Upstate Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: University Hospital, Augusta, Georgia, USA
name: Robert Mendes, MD
role: PRINCIPAL_INVESTIGATOR
References: