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Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3 ("RETRIEVE 3")

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crux Biomedical
ClinicalTrials.gov Identifier:
NCT01120522
First received: May 6, 2010
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Pulmonary Embolism
 Device: Inferior Vena Cava Filter
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Crux Biomedical:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention.


Secondary Outcome Measures:
  • Retrieval Success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Filter Migration [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • VCF Thrombus [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Device Integrity [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crux Vena Cava Filter System
Subjects at risk for Pulmonary Embolism
 Device: Inferior Vena Cava Filter
Inplant of filter in inferior vena cava.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120522

Locations
Belgium
Imelda Hospital
Bonheiden, Belgium
A. Z. St. Blasius Hospital
Dendermonde, Belgium
Sponsors and Collaborators
Crux Biomedical
  More Information

No publications provided

Responsible Party: Crux Biomedical
ClinicalTrials.gov Identifier: NCT01120522     History of Changes
Other Study ID Numbers: Crux03
Study First Received: May 6, 2010
Last Updated: February 8, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products

Keywords provided by Crux Biomedical:
Vena Cava
Vena Cava Filter
Pulmonary Embolism
Venous Thromboembolism
Risk of Pulmonary Embolism

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013