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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crux Biomedical
ClinicalTrials.gov Identifier:
NCT00605332
First received: January 2, 2008
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Pulmonary Embolism
Device: inferior vena cava filter
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System - ("Retrieve")

Resource links provided by NLM:


Further study details as provided by Crux Biomedical:

Primary Outcome Measures:
  • 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. [ Time Frame: 30 days post implant, 30 days post retrieval. Patients with indwelling filters will return 1 and 6 months post implant procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Primary Safety Objective: To estimate the proportion of patients who experience device/procedure related complications associated with the Crux IVCF. [ Time Frame: 30 days post implant procedure and 30 days post retrieval procedure. Patients with indwelling filters will return 1 and 6 months post implant procedure. ] [ Designated as safety issue: Yes ]

Enrollment: 88
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: No other names

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605332

Sponsors and Collaborators
Crux Biomedical
Investigators
Principal Investigator: David Rosenthal, MD Atlanta Vascular Specialists
Study Director: Mel Schatz Crux Biomedical
  More Information

No publications provided

Responsible Party: Crux Biomedical
ClinicalTrials.gov Identifier: NCT00605332     History of Changes
Other Study ID Numbers: RETRIEVE I, G070035
Study First Received: January 2, 2008
Last Updated: August 3, 2012
Health Authority: United States: Food and Drug Administration

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 April 17, 2014