Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4

Overview

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

Full Title of Study: “Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 4 (RETRIEVE 4)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Clinical Success
    • Time Frame: 6 Months
    • Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.

Secondary Measures

  • Rates of complications related to vena cava filter use.
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Crux Biomedical
  • Provider of Information About this Clinical Study
    • Sponsor

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