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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00605332

Acronym

Retrieve

Enrollment

Registered

2008-01-31

Start date

2007-10-31

Completion date

2009-07-31

Last updated

2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Brief summary

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

Interventions

DEVICEinferior vena cava filter

Crux Biomedical IVC Filter

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026