Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3 ("RETRIEVE 3") (RETRIEVE 3)
Primary Purpose
Pulmonary Embolism
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Inferior Vena Cava Filter
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring Vena Cava, Vena Cava Filter, Pulmonary Embolism, Venous Thromboembolism, Risk of Pulmonary Embolism
Eligibility Criteria
Inclusion Criteria:
- Patient has a permanent or temporary risk of Pulmonary Embolism.
- Patient must provide informed consent At least one of the following conditions -
- Proven PE
- Recurrent PE despite adequate
- 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
- Protection during thrombolysis for iliocaval DVT
- PE with limited cardiopulmonary reserve
- Poor compliance with anticoagulation medication
- High risk of injury worsening on anticoagulation
- Multi-trauma patient with high risk of PE
- Surgical patients at high risk of PE
- Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is 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 the renal veins
- Duplicate IVC
- Gonadal vein thrombosis
- Requires supra-renal placement
- Vena cava diameter of 17-28mm
- 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 same insertion of delivery system
- Participation in another drug or device trial
- Unable or unwilling to cooperate with study procedures or required follow-up visits
Sites / Locations
- Imelda Hospital
- A. Z. St. Blasius Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Crux Vena Cava Filter System
Arm Description
Subjects at risk for Pulmonary Embolism
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Retrieval Success
Filter Migration
VCF Thrombus
Device Integrity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01120522
Brief Title
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3 ("RETRIEVE 3")
Acronym
RETRIEVE 3
Official Title
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crux Biomedical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Vena Cava, Vena Cava Filter, Pulmonary Embolism, Venous Thromboembolism, Risk of Pulmonary Embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crux Vena Cava Filter System
Arm Type
Experimental
Arm Description
Subjects at risk for Pulmonary Embolism
Intervention Type
Device
Intervention Name(s)
Inferior Vena Cava Filter
Intervention Description
Inplant of filter in inferior vena cava.
Primary Outcome Measure Information:
Title
Clinical Success
Description
Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Retrieval Success
Time Frame
6 months
Title
Filter Migration
Time Frame
6 Months
Title
VCF Thrombus
Time Frame
6 Months
Title
Device Integrity
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has a permanent or temporary risk of Pulmonary Embolism.
Patient must provide informed consent At least one of the following conditions -
Proven PE
Recurrent PE despite adequate
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
Protection during thrombolysis for iliocaval DVT
PE with limited cardiopulmonary reserve
Poor compliance with anticoagulation medication
High risk of injury worsening on anticoagulation
Multi-trauma patient with high risk of PE
Surgical patients at high risk of PE
Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is 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 the renal veins
Duplicate IVC
Gonadal vein thrombosis
Requires supra-renal placement
Vena cava diameter of 17-28mm
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 same insertion of delivery system
Participation in another drug or device trial
Unable or unwilling to cooperate with study procedures or required follow-up visits
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
Country
Belgium
Facility Name
A. Z. St. Blasius Hospital
City
Dendermonde
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23622035
Description
Smouse H, Mendes R, Bosiers M et al. The RETRIEVE Trial: Safety and Effectiveness of the Retrieval Crux Vena Cava Filter. JVIR 2013; 24:609-621.
Learn more about this trial
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3 ("RETRIEVE 3")
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