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OpenTrials
Completed

NCT Number: NCT05785676

ALN 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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP - Hôpital Européen Georges-Pompidou Paris, France

Paris, Île-de-France Region, 75908, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filter implantation

Device

Implantation of OATF ALN vena cava filter

Primary outcomes

  1. Filter implantation

    Time frame: day 0

    Rate of technical success of filter implantation

Secondary outcomes

  1. Filter removal

    Time frame: up to 1 year

    Rate of filter removal

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Aln2b SARL

Registry information

Official study title

Study of ALN's OATF Vena Cava Filter

Acronym: CONFIAL

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 27, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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