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OpenTrials
Completed

NCT Number: NCT00488865

RexMedical- Option* Vena Cava Filter IDE Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peninsula Surgical Specialists Medical Group, Inc., Burlingame, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravascular Filter Device

Device

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.

Primary outcomes

  1. Percentage of Participants With Clinical Success

    Time frame: up to 180 days

    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.

  2. Percentage of Participants With Retrieval Clinical Success

    Time frame: upto 175 days

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

Secondary outcomes

  1. Placement Technical Success

    Time frame: Immediately post placement procedure

    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.

Sponsors and collaborators

Lead sponsor

Rex Medical

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jun 20, 2007
Registry last updated
Aug 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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