Crux Biomedical Vena Cava Filter Study - United States (RETRIEVE 2)
This study has been completed.
Sponsor:
Crux Biomedical
Information provided by (Responsible Party):
Crux Biomedical
ClinicalTrials.gov Identifier:
NCT01120509
First received: April 29, 2010
Last updated: August 3, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Embolism |
Device: Inferior Vena Cava Filter |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2 |
Resource links provided by NLM:
Further study details as provided by Crux Biomedical:
Primary Outcome Measures:
- Clinical Success [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.
Secondary Outcome Measures:
- Retrieval Success [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Filter Migration [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- VCF Thrombus [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Device Integrity [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
| Enrollment: | 88 |
| Study Start Date: | June 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Crux Vena Cava Filter System
Subjects at risk for Pulmonary Embolism
|
Device: Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120509
Locations
| United States, California | |
| St. Joseph's Hospital | |
| Orange, California, United States, 92868 | |
| University of California at Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Univeristy of California at Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| United States, Delaware | |
| Christiana Care | |
| Newark, Delaware, United States | |
| United States, Florida | |
| University of Florida Medical Center | |
| Gainesville, Florida, United States, 32610 | |
| United States, Georgia | |
| Atlanta Medical Center | |
| Atlanta, Georgia, United States, 30312 | |
| University Hospital | |
| Augusta, Georgia, United States, 30901 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| St. Francis Hospital | |
| Peoria, Illinois, United States, 61637 | |
| United States, Maryland | |
| Anne Arundel Medical Center | |
| Annapolis, Maryland, United States, 21401 | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Upstate Medical Center | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| University of North Carolina Medical Center | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Jobst Vascular Institute | |
| Toledo, Ohio, United States, 43606 | |
| United States, Pennsylvania | |
| Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Virginia | |
| University of Virginia Medical Center | |
| Charlottesville, Virginia, United States | |
Sponsors and Collaborators
Crux Biomedical
Investigators
| Principal Investigator: | Robert Mendes, MD | University Hospital, Augusta, Georgia, USA |
More Information
No publications provided
| Responsible Party: | Crux Biomedical |
| ClinicalTrials.gov Identifier: | NCT01120509 History of Changes |
| Other Study ID Numbers: | Crux02 |
| Study First Received: | April 29, 2010 |
| Last Updated: | August 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Crux Biomedical:
|
Vena Cava Vena Cava Filter Pulmonary Embolism Venous Thromboembolism Risk of Pulmonary Embolism |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013