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

B. Braun

Status: Completed

Conditions: Pulmonary Thrombo-embolism

Treatments: Device: VenaTech® (VenaTech Retrievable Filter)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02674672

AAG-G-H-1419

Details and patient eligibility

About

To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

VenaTech Retrievable arm

Experimental group

Description:

VenaTech Retrievable arm

Treatment:

Device: VenaTech® (VenaTech Retrievable Filter)