ALN OATF Vena Cava Filter

NCT05785676 | Completed

• 2 other identifiers: APHP2205702022-A00915-38
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism

Keywords

Vena Cava Filter

Outcome Measures

Primary Outcomes (1)

• Filter implantation

  Rate of technical success of filter implantation

  day 0

Secondary Outcomes (1)

• Filter removal

  up to 1 year

Study Arms (1)

Vena Cava Filter

Participants implanted with the vena cava filter OATF (ALN)

Device: Filter implantation

Interventions

Filter implantation DEVICE

Implantation of OATF ALN vena cava filter

Vena Cava Filter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients requiring a vena cave filter

You may qualify if:

• Patient implanted with an ALN OATF VCF
• Patient informed

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Aln2b SARL: collaborator

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Olivier PELLERIN, MD - PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 27, 2023
• Study Start: February 14, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• 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).

Locations

FR (1)