Crux Biomedical IVC Filter - Evaluation of the Crux Inferior Vena Cava Filter System (Retrieve) (Retrieve)

Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System - ("Retrieve")

This is an open label, non-randomized, prospective, multicenter study.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: inferior vena cava filter

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

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:

Patients for this study must meet the following inclusion criteria to be eligible for enrollment:

1. The patient is >18 years of age.

2. Patient is considered a candidate for the IVCF under one of the following indications:

   • Proven PE
   • Recurrent PE despite adequate anticoagulation
   • Contraindication to anticoagulation
   • Inability to achieve/maintain therapeutic anticoagulation
   • Iliocaval DVT
   • Large, free-floating proximal (i.e. ileofemoral) 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 anticoagulant medications
   • High risk of injury worsened by anticoagulation (e.g., ataxia, falls)
   • Multi-trauma patient with high risk of PE
   • Surgical patients at high risk of PE
   • Medical condition with high risk of PE
3. Patient has a vena cava diameter of 17-28mm.
4. The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
5. The patient is willing to be available for the appropriate follow-up for the duration of the study.
6. The patient has suitable IVC anatomy that would allow infra-renal placement of the filter.

Exclusion Criteria:

Patients who have ANY of the following exclusion criteria are NOT eligible for the study:

1. The patient has one of the following conditions:

   • Renal vein thrombosis
   • IVC thrombosis extending to renal veins
   • Duplicate IVC
   • Gonadal vein thrombosis
   • Requires supra-renal filter placement
2. The patient has an uncontrolled infectious disease.
3. The patient is at risk for aseptic PE.
4. Patient has uncontrollable coagulopathy.
5. Patient has an existing IVCF.
6. The patient has a life expectancy of less than 6 months.
7. The patient is pregnant.
8. The patient has a condition that inhibits radiographic visualization of the IVC.
9. The patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol.
10. The patient has a known hypersensitivity to contrast which cannot be pre-treated.
11. The patient's access vessels preclude safe insertion of the delivery system.
12. The patient is participating in another device or drug study. Patient must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this trial. The patient may only be enrolled in this study once.
13. The patient is unable and/or unwilling to cooperate with study procedures or required follow-up visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Investigative Device (Crux Biomedical IVC Filter) will be evaluated for its ability to capture thrombus for the prevention of pulmonary embolism.	Device: inferior vena cava filter; Crux Biomedical IVC Filter; Other Names: No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Efficacy Objective: To describe the clinical utility of the Crux IVCF by the following criteria: Absence of a recurrent PE and IVC thrombosis related to the Crux IVCF.	30 days post implant, 30 days post retrieval. Patients with indwelling filters will return 1 and 6 months post implant procedure.

Secondary Outcome Measures

Outcome Measure	Time Frame
Primary Safety Objective: To estimate the proportion of patients who experience device/procedure related complications associated with the Crux IVCF.	30 days post implant procedure and 30 days post retrieval procedure. Patients with indwelling filters will return 1 and 6 months post implant procedure.

Collaborators and Investigators

• Sponsor: Crux Biomedical
• Investigators: Principal Investigator: David Rosenthal, MD, Atlanta Vascular Specialists; Study Director: Mel Schatz, Crux Biomedical

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: January 2, 2008
• First Submitted That Met QC Criteria: January 30, 2008
• First Posted (Estimate): January 31, 2008

Study Record Updates

• Last Update Posted (Estimate): August 6, 2012
• Last Update Submitted That Met QC Criteria: August 3, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: RETRIEVE I; G070035