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NCT Number: NCT06631157

Essential Pro Study ( rEPIC04E-HK )

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

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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

Princess Margaret Hospital

Lai Chi Kok, Hong Kong

Location status: Recruiting

About this study

This study intends to analyze:

  • Device effectiveness (in its individual use, technical performance) and procedural effectiveness (technical outcome at the end of lesion treatment with the device under study and any other device being used).
  • Device safety (in its individual use, technical performance) and procedural safety (technical outcome at the end of lesion treatment with the device under study and any other device being used).
  • Clinical outcomes at the end of the procedure and during the specified follow-up period for each device. The follow-up timeframe is established based on the conditions of use and type of device being used, according to the requirements established by the relevant Notified Body.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Not meet inclusion criteria

Treatment and study plan

Essential pro

Device

Patients in whom treatment with (Essential Pro) has been attempted

Primary outcomes

  1. Safety Endpoint. Freedom from Target Lesion Failure

    Time frame: 12 months

    Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR). 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: 12 months

    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

    Freedom from Balloon rupture

  3. Freedom from Hypotube rupture

    Time frame: During PCI

    Freedom from Hypotube rupture

  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

Study contacts

Contact information is provided by the study sponsor or research team.

FUNDACION EPIC

CONTACT

[email protected]

0034987225638

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

Essential Pro Post-Market Clinical Follow-up Study

Acronym: rEPIC04E-HK

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Feb 17, 2026

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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