Crux Biomedical Vena Cava Filter Study - United States
RETRIEVE 2
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2
1 other identifier
interventional
88
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2010
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2010
CompletedFirst Posted
Study publicly available on registry
May 11, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJune 30, 2014
August 1, 2012
1 year
April 29, 2010
June 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Success
Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.
6 Months
Secondary Outcomes (4)
Retrieval Success
6 Months
Filter Migration
6 Months
VCF Thrombus
6 Months
Device Integrity
6 Months
Study Arms (1)
Crux Vena Cava Filter System
EXPERIMENTALSubjects at risk for Pulmonary Embolism
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Crux Biomedicallead
Study Sites (17)
St. Joseph's Hospital
Orange, California, 92868, United States
University of California at Irvine Medical Center
Orange, California, 92868, United States
Univeristy of California at Davis Medical Center
Sacramento, California, 95817, United States
Christiana Care
Newark, Delaware, United States
University of Florida Medical Center
Gainesville, Florida, 32610, United States
Atlanta Medical Center
Atlanta, Georgia, 30312, United States
University Hospital
Augusta, Georgia, 30901, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
St. Francis Hospital
Peoria, Illinois, 61637, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Albany Medical Center
Albany, New York, 12208, United States
Upstate Medical Center
Syracuse, New York, 13210, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599, United States
Jobst Vascular Institute
Toledo, Ohio, 43606, United States
Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Mendes, MD
University Hospital, Augusta, Georgia, USA
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2010
First Posted
May 11, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2011
Study Completion
January 1, 2012
Last Updated
June 30, 2014
Record last verified: 2012-08