Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4

Pulmonary Embolism Clinical Trial

— RETRIEVE 4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120535
• Other study ID #: Crux04
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2010
• Last updated: June 26, 2014
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Crux Biomedical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.

Locations

Country	Name	City	State
Australia	Royal Brisbane Womens Hospital	Brisbane
Australia	The Alfred Hospital	Melbourne
New Zealand	Auckland City Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Crux Biomedical

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 Months	Yes
Secondary	Rates of complications related to vena cava filter use.		6 months	Yes

External Links

•   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.