Pulmonary Embolism Clinical Trial
— RETRIEVE 2Official title:
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2
Verified date | August 2012 |
Source | Crux Biomedical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.
Status | Completed |
Enrollment | 88 |
Est. completion date | January 2012 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical Center | Albany | New York |
United States | Anne Arundel Medical Center | Annapolis | Maryland |
United States | Atlanta Medical Center | Atlanta | Georgia |
United States | University Hospital | Augusta | Georgia |
United States | University of North Carolina Medical Center | Chapel Hill | North Carolina |
United States | University of Virginia Medical Center | Charlottesville | Virginia |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | University of Florida Medical Center | Gainesville | Florida |
United States | Hershey Medical Center | Hershey | Pennsylvania |
United States | Christiana Care | Newark | Delaware |
United States | St. Joseph's Hospital | Orange | California |
United States | University of California at Irvine Medical Center | Orange | California |
United States | St. Francis Hospital | Peoria | Illinois |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Univeristy of California at Davis Medical Center | Sacramento | California |
United States | Upstate Medical Center | Syracuse | New York |
United States | Jobst Vascular Institute | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
Crux Biomedical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Retrieval Success | 6 Months | Yes | |
Secondary | Filter Migration | 6 Months | Yes | |
Secondary | VCF Thrombus | 6 Months | Yes | |
Secondary | Device Integrity | 6 Months | Yes |
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