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

NCT00605332 | Completed Phase 2 DMC

• 2 other identifiers: RETRIEVE IG070035
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

inferior vena cava filter DEVICE

Crux Biomedical IVC Filter

Also known as: No other names

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is \>18 years of age.
• 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

You may not qualify if:

• 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
• The patient has an uncontrolled infectious disease.
• The patient is at risk for aseptic PE.
• Patient has uncontrollable coagulopathy.
• Patient has an existing IVCF.
• The patient has a life expectancy of less than 6 months.
• The patient is pregnant.
• The patient has a condition that inhibits radiographic visualization of the IVC.
• The patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol.
• The patient has a known hypersensitivity to contrast which cannot be pre-treated.

Sponsors & Collaborators

• Crux Biomedical: lead

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Vena Cava Filters

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Embolic Protection Devices; Prostheses and Implants; Equipment and Supplies

Study Officials

• David Rosenthal, MD

  Atlanta Vascular Specialists

  PRINCIPAL INVESTIGATOR

• Mel Schatz

  Crux Biomedical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 31, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2009
• Last Updated: August 6, 2012

Record last verified: 2012-08