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Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4 (RETRIEVE 4)

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 3
Locations
International
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 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

  • Royal Brisbane Womens Hospital
  • The Alfred Hospital
  • Auckland City 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

Rates of complications related to vena cava filter use.

Full Information

First Posted
May 6, 2010
Last Updated
June 26, 2014
Sponsor
Crux Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT01120535
Brief Title
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4
Acronym
RETRIEVE 4
Official Title
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 4 (RETRIEVE 4)
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
20 (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
Rates of complications related to vena cava filter use.
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
Royal Brisbane Womens Hospital
City
Brisbane
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
Country
Australia
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand

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.

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Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4

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