Crux Biomedical Vena Cava Filter Study - United States (RETRIEVE 2)

Crux Biomedical

Status and phase: Completed; Phase 3

Conditions: Pulmonary Embolism

Treatments: Device: Inferior Vena Cava Filter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01120509

Crux02

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a permanent or temporary risk of Pulmonary Embolism

• Patient or legal guardian must provide written informed consent

• At least one of the following conditions

  • Proven PE
  • Recurrent PE despite adequate anticoagulation
  • 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
  • Procetion during thrombolysis for iliocaval DVT
  • PE with limited cardiopulmonary reserve
  • Poor compliance with anticoagulation medication
  • High risk of injury worsend by anticoagulation
  • Multi-trauma patient with high risk of PE
  • Surgical patients at high risk of PE
  • Medical condition with high risk of PE

• Patient has documented vena cava diameter of 17-28mm

• Patient has IVC anatomy suitable for infra-renal placement

• Patient 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 te renal veins
  • Duplicate IVC
  • Gonadal vein thrombosis
  • Requires supra-renal placement

• 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 safe insertion of delivery system

• Participation in another drug or device trial

• Unable or unwilling to cooperate with study procedures or required follow-up visits

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Crux Vena Cava Filter System

Experimental group

Description:

Subjects at risk for Pulmonary Embolism

Treatment:

Device: Inferior Vena Cava Filter