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

Not Applicable

Completed

• Conditions: Pulmonary Thrombo-embolism
• Interventions: Device: VenaTech® (VenaTech Retrievable Filter)

• Registration Number: NCT02674672
• Lead Sponsor: B.Braun Médical - CoE Chasseneuil

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2016-02
• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-04
• Primary Completion: 2017-02
• Study Completion: 2017-05
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VenaTech Retrievable arm	VenaTech® (VenaTech Retrievable Filter)	VenaTech Retrievable arm

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital européen Georges Pompidou; 🇫🇷 Paris, France