ALN OATF Vena Cava Filter

NCT ID: NCT05785676

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-14

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vena Cava Filter

Participants implanted with the vena cava filter OATF (ALN)

Filter implantation

Intervention Type DEVICE

Implantation of OATF ALN vena cava filter

Interventions

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Filter implantation

Implantation of OATF ALN vena cava filter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aln2b SARL

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier PELLERIN, MD - PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Breno MELO, PhD

Role: CONTACT

+33140271840

Carole Déan, PhD

Role: CONTACT

+33156093719

Facility Contacts

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Olivier Pellerin, MD - PhD

Role: primary

Other Identifiers

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2022-A00915-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220570

Identifier Type: -

Identifier Source: org_study_id

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