CONFIAL: ALN OATF Vena Cava Filter

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT05785676

Collaborator

Aln2b SARL (Other)

Enrollment

Location

35.6

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism	Device: Filter implantation

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of ALN's OATF Vena Cava Filter

Actual Study Start Date :

Feb 14, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Vena Cava Filter

Participants implanted with the vena cava filter OATF (ALN)

Device: Filter implantation

Implantation of OATF ALN vena cava filter

Outcome Measures

Primary Outcome Measures

Filter implantation [day 0]
Rate of technical success of filter implantation

Secondary Outcome Measures

Filter removal [up to 1 year]
Rate of filter removal

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP - Hôpital Européen Georges-Pompidou Paris, France	Paris	Ile-de-France	France	75908

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris
Aln2b SARL

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT05785676

Other Study ID Numbers:

APHP220570
2022-A00915-38

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Vena Cava Filter

Additional relevant MeSH terms:

Pulmonary Embolism

Embolism

Study Results

No Results Posted as of Mar 27, 2023