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Crux Biomedical Vena Cava Filter Study - United States (RETRIEVE 2)

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Inferior Vena Cava Filter
Sponsored by
Crux Biomedical
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital
  • University of California at Irvine Medical Center
  • Univeristy of California at Davis Medical Center
  • Christiana Care
  • University of Florida Medical Center
  • Atlanta Medical Center
  • University Hospital
  • University of Chicago Medical Center
  • St. Francis Hospital
  • Anne Arundel Medical Center
  • Albany Medical Center
  • Upstate Medical Center
  • University of North Carolina Medical Center
  • Jobst Vascular Institute
  • Hershey Medical Center
  • University of Pittsburgh Medical Center
  • University of Virginia Medical Center

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

First Posted
April 29, 2010
Last Updated
June 26, 2014
Sponsor
Crux Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT01120509
Brief Title
Crux Biomedical Vena Cava Filter Study - United States
Acronym
RETRIEVE 2
Official Title
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 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
88 (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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Mendes, MD
Organizational Affiliation
University Hospital, Augusta, Georgia, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California at Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Univeristy of California at Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Christiana Care
City
Newark
State/Province
Delaware
Country
United States
Facility Name
University of Florida Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Atlanta Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
University Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
St. Francis Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Upstate Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Jobst Vascular Institute
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
Country
United States

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 Vena Cava Filter Study - United States

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