| Eligibility |
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)
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