ALN OATF Vena Cava Filter

Pulmonary Embolism Clinical Trial

— CONFIAL  

Official title:

Study of ALN's OATF Vena Cava Filter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785676
• Other study ID #: APHP220570
• Secondary ID: 2022-A00915-38
• Status: Recruiting
• Start date: February 14, 2023
• Est. completion date: February 2026

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Breno MELO, PhD
• Phone: +33140271840
• Email: gestion-locale.drc[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Filter implantation
Implantation of OATF ALN vena cava filter

Locations

Country	Name	City	State
France	AP-HP - Hôpital Européen Georges-Pompidou Paris, France	Paris	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Aln2b SARL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Filter implantation	Rate of technical success of filter implantation	day 0
Secondary	Filter removal	Rate of filter removal	up to 1 year