Pulmonary Thrombo-embolism
Conditions
Keywords
VenaTech® Retrievable Vena Cava Filter, safety, efficacy
Brief summary
To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter
Interventions
DEVICEVenaTech® (VenaTech Retrievable Filter)
Sponsors
B.Braun Médical - CoE Chasseneuil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | 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 |
Countries
France
Outcome results
None listed