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

Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Inferior Vena Cava Filter

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California at Irvine Medical Center
    • Orange, California, United States, 92868
      • St. Joseph's Hospital
    • Sacramento, California, United States, 95817
      • Univeristy of California at Davis Medical Center
  • Delaware
    • Newark, Delaware, United States
      • Christiana Care
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Atlanta Medical Center
    • Augusta, Georgia, United States, 30901
      • University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Peoria, Illinois, United States, 61637
      • St. Francis Hospital
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Syracuse, New York, United States, 13210
      • Upstate Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Medical Center
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Jobst Vascular Institute
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Virginia
    • Charlottesville, Virginia, United States
      • University of Virginia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crux Vena Cava Filter System; Subjects at risk for Pulmonary Embolism	Device: Inferior Vena Cava Filter; Inplant of filter in inferior vena cava.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Retrieval Success	6 Months
Filter Migration	6 Months
VCF Thrombus	6 Months
Device Integrity	6 Months

Collaborators and Investigators

• Sponsor: Crux Biomedical
• Investigators: Principal Investigator: Robert Mendes, MD, University Hospital, Augusta, Georgia, USA

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: May 7, 2010
• First Posted (Estimate): May 11, 2010

Study Record Updates

• Last Update Posted (Estimate): June 30, 2014
• Last Update Submitted That Met QC Criteria: June 26, 2014
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Venous Thromboembolism; Pulmonary Embolism; Vena Cava; Vena Cava Filter; Risk of Pulmonary Embolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: Crux02