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Completed

NCT Number: NCT05292118

Navitian PMCF Study ( rEPIC04C )

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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient treated with Navitian according to routine hospital practice and following instructions for use
  • Informed consent signed

Exclusion criteria

  • Not meet inclusion criteria

Treatment and study plan

Navitian

Device

Patients in whom treatment with (Navitian) has been attempted

Primary outcomes

  1. Safety Endpoint. Freedom fromTarget Lesion Failure

    Time frame: 7 days

    Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

Secondary outcomes

  1. Efficacy Endpoint. Freedom from Target Lesion Failure

    Time frame: 7 days

    Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

  2. Freedom from Device rupture

    Time frame: During percutaneous coronary intervention (PCI)

    Freedom from Device rupture

  3. Freedom from Kinking

    Time frame: During PCI

    Freedom from Kinking

  4. Freedom from Complicated withdrawal

    Time frame: During PCI

    Freedom from Complicated withdrawal

  5. Freedom from Coronary perforation

    Time frame: During PCI

    Freedom from Coronary perforation

  6. Freedom from Coronary dissection >C

    Time frame: During PCI

    Freedom from Coronary dissection >C

  7. Freedom from No reflow

    Time frame: During PCI

    Freedom from No reflow

  8. Freedom from Coronary thrombosis

    Time frame: During PCI

    Freedom from Coronary thrombosis

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

Navitian Post-Market Clinical Follow-up Study

Acronym: rEPIC04C

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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