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NCT Number: NCT05706805

NAVISCORE PMCF Study ( rEPIC04F )

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases 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

Hospital Clinic de Barcelona, Barcelona, Spain

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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 Naviscore scoring balloon 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

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

Inclusion criteria

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

Exclusion criteria

  • Not meet inclusion criteria

Treatment and study plan

Naviscore

Device

Patients in whom treatment with (Naviscore) has been attempted

Primary outcomes

  1. Safety Endpoint. Freedom from Target Lesion Failure

    Time frame: 7 days

    Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).

Secondary outcomes

  1. Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)

    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 Balloon rupture

    Time frame: During PCI (Percutaneous Coronary Intervention)

    Freedom from Balloon rupture

  3. Freedom from Hypotube rupture

    Time frame: During PCI (Percutaneous Coronary Intervention)

    Freedom from Hypotube rupture ( partial or total fracture of the shaft of the device)

  4. Freedom from Complicated withdrawal

    Time frame: During PCI (Percutaneous Coronary Intervention)

    Freedom from Complicated withdrawal (difficult or impossible device retrieval that may or may not cause clinical complications)

  5. Freedom from Coronary perforation

    Time frame: During PCI (Percutaneous Coronary Intervention)

    Freedom from Coronary perforation according to the modified Ellis classification

  6. Freedom from Coronary dissection >C

    Time frame: During PCI (Percutaneous Coronary Intervention)

    Freedom from Coronary dissection >C according to the NHLBI Classification (National Heart, Lung, and Blood Institute)

  7. Freedom from No reflow

    Time frame: During PCI (Percutaneous Coronary Intervention)

    Freedom from No reflow (persistently slowed flow with residual stenosis <30% and no flow-limiting dissection)

  8. Freedom from Coronary thrombosis

    Time frame: During PCI (Percutaneous Coronary Intervention)

    Freedom from Coronary thrombosis according to ARC-2 ( Academic Research Consortium-2) criteria

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

NAVISCORE Post-Market Clinical Follow-up Study

Acronym: rEPIC04F

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2023
Registry last updated
Feb 6, 2024

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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