RexMedical- Option* Vena Cava Filter IDE Study

Rex Medical

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Device: Intravascular Filter Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00488865

REX-US-2006-001

Details and patient eligibility

About

This study is designed to evaluate the safety and efficacy of the RexMedical Option* Vena Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and require caval interruption.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Patient is at least 18 years of age
• Patient requires temporary or permanent caval interruption

Key Exclusion Criteria:

• Patient has pre-existing filter implanted in her/her vasculature or has undergone filter retrieval within 60 days prior to study device implant
• Patient is currently enrolled in another investigational device or drug trial

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Intravascular Filter Device

Other group

Treatment:

Device: Intravascular Filter Device