A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System

Study Overview
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Brief Summary
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To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter

Official Title
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A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System

Conditions
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Pulmonary Thrombo-embolism

Intervention / Treatment
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* Device: VenaTech® (VenaTech Retrievable Filter)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pulmonary thrombo-embolism with contraindication to anticoagulation. Failure of anticoagulant therapy in thrombo-embolic diseases. Prevention of pulmonary embolism in patients with a recent history ( <3 months) of DVT/ PE who need to undergo urgent surgery at high risk of DVT/PE with temporary contra-indication to the use of therapeutic doses of anticoagulants. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated Exclusion Criteria: The filter should not be implanted in patients with : A vena cava which has a diameter < 14 mm or > 28 mm (due to the risk of device migration) Risk of septic embolism Known allergy to the materials contained in the kit, allergy to contrast media. Severely disabled patients whose life-expectancy, up to 6 months, appears limited according to the investigator's opinion. In addition, exclusion criteria are also extended to : Patients who cannot be regularly followed up by the participating center Subject who already has an implanted vena cava filter Subject who has a duplicated IVC Subject who has a contrast allergy to both iodinated contrast and non-iodinated contrast material Subject unable to understand information about participation in the study due to a language barrier, intellectual deficiency, psychiatric problems… Subject who has a renal failure (creatinemia clearance < 30ml/min)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VenaTech Retrievable arm<br>VenaTech Retrievable arm | Device: VenaTech® (VenaTech Retrievable Filter)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and the efficacy of filter implantation and retrieval by the study of technical success rate of filter placement, and filter removal (when filter removal procedure is schedule) within 12 weeks of implantation |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VenaTech® Retrievable Vena Cava Filter, safety, efficacy