RexMedical- Option* Vena Cava Filter IDE Study

Rex Medical100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Pulmonary Embolism

Interventions

Intravascular Filter DeviceDEVICE

Vena cava filter which is implanted into the inferior vena cava of patients to prevent recurrent pulmonary embolism. The filter can be utilized as a permanent or retrievable device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Peninsula Surgical Specialists Medical Group, Inc.

Burlingame, California, United States

Christiana Care Health System

Newark, Delaware, United States

George Washington University

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Percentage of Participants With Clinical Success

Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.

Time frame: up to 180 days

Percentage of Participants With Retrieval Clinical Success

Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.

Time frame: upto 175 days

Secondary Outcomes

Placement Technical Success

Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism.

Time frame: Immediately post placement procedure

Data from ClinicalTrials.gov

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