Navitian PMCF Study ( rEPIC04C )

NCT ID: NCT05292118

Last Updated: 2025-03-05

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

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-26

Study Completion Date

2024-07-11

Brief Summary

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Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Navitian to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Navitian.

Detailed Description

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The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Navitian in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Conditions

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Coronary Artery Disease (CAD) Ischemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Artery Disease (CAD)

Navitian

Intervention Type DEVICE

Patients in whom treatment with (Navitian) has been attempted

Interventions

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Navitian

Patients in whom treatment with (Navitian) has been attempted

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient treated with Navitian according to routine hospital practice and following instructions for use
* Informed consent signed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación EPIC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centro Hospitalar Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

Site Status

Hospital Universitari Vall D'Hebron

Barcelona, , Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario Juan Ramon Jimenez

Huelva, , Spain

Site Status

Hospital Universitario de Leon

León, , Spain

Site Status

Hospital Universitario Lucus Agusti

Lugo, , Spain

Site Status

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Site Status

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Site Status

Countries

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Portugal Spain

References

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Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available.

Reference Type BACKGROUND
PMID: 74678 (View on PubMed)

Obata JE, Nakamura T, Kitta Y, Saito Y, Sano K, Fujioka D, Kawabata K, Kugiyama K. Usefulness of a collateral channel dilator for antegrade treatment of chronic total occlusion of a coronary artery. J Interv Cardiol. 2012 Dec;25(6):533-9. doi: 10.1111/j.1540-8183.2012.00758.x. Epub 2012 Jul 23.

Reference Type BACKGROUND
PMID: 22823494 (View on PubMed)

Other Identifiers

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Navitian PMCF Study

Identifier Type: -

Identifier Source: org_study_id

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