search
Back to results

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

Primary Purpose

Pulmonary Thrombo-embolism

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VenaTech® (VenaTech Retrievable Filter)
Sponsored by
B.Braun Médical - CoE Chasseneuil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Thrombo-embolism focused on measuring VenaTech® Retrievable Vena Cava Filter, safety, efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Hopital européen Georges Pompidou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VenaTech Retrievable arm

Arm Description

VenaTech Retrievable arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2016
Last Updated
February 1, 2021
Sponsor
B.Braun Médical - CoE Chasseneuil
search

1. Study Identification

Unique Protocol Identification Number
NCT02674672
Brief Title
A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
Official Title
A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B.Braun Médical - CoE Chasseneuil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Thrombo-embolism
Keywords
VenaTech® Retrievable Vena Cava Filter, safety, efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VenaTech Retrievable arm
Arm Type
Experimental
Arm Description
VenaTech Retrievable arm
Intervention Type
Device
Intervention Name(s)
VenaTech® (VenaTech Retrievable Filter)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Hopital européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36194306
Citation
Dean C, Kim YI, Sanchez O, Martelli N, Sapoval M, Pellerin O. Safety and efficacy of the VenaTech Retrievable inferior vena cava filter: a first-in-man single-center prospective study. CVIR Endovasc. 2022 Oct 4;5(1):50. doi: 10.1186/s42155-022-00325-y.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs