A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter
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)