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

February 1, 2021 updated by: B.Braun Médical - CoE Chasseneuil
To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75908
        • Hôpital Européen Georges Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VenaTech Retrievable arm
Device: VenaTech® (VenaTech Retrievable Filter)

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.Braun Médical - CoE Chasseneuil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-G-H-1419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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