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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Pulmonary Thrombo-embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VenaTech Retrievable arm

Group Type EXPERIMENTAL

VenaTech® (VenaTech Retrievable Filter)

Intervention Type DEVICE

Interventions

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VenaTech® (VenaTech Retrievable Filter)

Intervention Type DEVICE

Eligibility Criteria

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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.

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No