A Safety and Efficacy Study for Implantation and Retrieva... | NCT02674672

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

NCT02674672

Sponsor

B.Braun Médical - CoE Chasseneuil

Status

Completed

Last Update Posted

Feb 3, 2021Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Pulmonary Thrombo-embolism

Interventions

VenaTech® (VenaTech Retrievable Filter)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Feb 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Feb 2, 2016

First Submission Date that Met QC Criteria

Feb 3, 2016

First Posted Date

Feb 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2021

Last Update Posted Date

Feb 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
VenaTech Retrievable arm	Experimental	VenaTech Retrievable arm	Device: VenaTech® (VenaTech Retrievable Filter)

Name	Type	Description	Arm Group Labels	Other Names
VenaTech® (VenaTech Retrievable Filter)	Device		VenaTech Retrievable arm

Measure	Description	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		12 weeks

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hopital européen Georges Pompidou		Paris		75908	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36194306	Derived	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.