ALN OATF Vena Cava Filter (CONFIAL)

April 14, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Study of ALN's OATF Vena Cava Filter

Migration of a thrombus in the pulmonary circulation is the leading cause of pulmonary embolism (PE). It can be prevented mechanically by implanting a vena cava filter (VCF) in the inferior vena cava. The implation of a VCF is indicated for patients with acute PE and a contraindication to anticoagulation, with an acute deep vein thrombosis (DVT) without PE and a contraindication to anticoagulation or with acute venous thromboembolism (less than 3 months) in whom an interventional gesture at hemorrhagic and thromboembolic risk contraindicates anticoagulation.

The purpose of this study is to describe the rates of implantation, removal and complications associated with the use of the optional ALN OATF VCF in current practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75908
        • Recruiting
        • AP-HP - Hôpital Européen Georges-Pompidou Paris, France
        • Contact:
          • Olivier Pellerin, MD - PhD

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

Sampling Method

Probability Sample

Study Population

Adult patients requiring a vena cave filter

Description

Inclusion Criteria:

  • Patient implanted with an ALN OATF VCF
  • Patient informed

Exclusion Criteria:

  • Minor patient
  • Adult patient under a legal protection measure
  • Pregnant, parturient or breastfeeding women
  • Patient who refused to participate
  • Patient who cannot or does not wish to be followed by the Interventional Radiology Department

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vena Cava Filter
Participants implanted with the vena cava filter OATF (ALN)
Device: Filter implantation
Implantation of OATF ALN vena cava filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Filter implantation
Time Frame: day 0
Rate of technical success of filter implantation
day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Filter removal
Time Frame: up to 1 year
Rate of filter removal
up to 1 year

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Aln2b SARL

Investigators

  • Principal Investigator: Olivier PELLERIN, MD - PhD, Assistance Publique - Hôpitaux de Paris

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)

February 14, 2023

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

February 1, 2026

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220570
  • 2022-A00915-38 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.

Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement.

Processing of shared data must comply with European General Data Protection Regulation (GDPR).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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