Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4

NCT01120535 | Completed Phase 3 DMC

• 1 other identifier: Crux04
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

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.

Conditions

Pulmonary Embolism

Keywords

Vena Cava; Vena Cava Filter; Pulmonary Embolism; Venous Thromboembolism; Risk of Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Rates of complications related to vena cava filter use.

  6 months

Study Arms (1)

Crux Vena Cava Filter System

EXPERIMENTAL

Subjects at risk for Pulmonary Embolism

Device: Inferior Vena Cava Filter

Interventions

Inferior Vena Cava Filter DEVICE

Inplant of filter in inferior vena cava.

Crux Vena Cava Filter System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Crux Biomedical: lead

Study Sites (3)

Royal Brisbane Womens Hospital

Brisbane, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

Auckland City Hospital

Auckland, New Zealand

Location

Related 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.

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thromboembolism

Interventions

Vena Cava Filters

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Intervention Hierarchy (Ancestors)

Embolic Protection Devices; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 11, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 30, 2014

Record last verified: 2012-02

Locations

AU (2); NZ (1)