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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01120535




Registration number
NCT01120535
Ethics application status
Date submitted
6/05/2010
Date registered
11/05/2010
Date last updated
30/06/2014

Titles & IDs
Public title
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4
Scientific title
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 4 (RETRIEVE 4)
Secondary ID [1] 0 0
Crux04
Universal Trial Number (UTN)
Trial acronym
RETRIEVE 4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Inferior Vena Cava Filter

Experimental: Crux Vena Cava Filter System - Subjects at risk for Pulmonary Embolism


Treatment: Devices: Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Success
Timepoint [1] 0 0
6 Months
Secondary outcome [1] 0 0
Rates of complications related to vena cava filter use.
Timepoint [1] 0 0
6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane Womens Hospital - Brisbane
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Crux Biomedical
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01120535
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01120535