Essential Pro Study ( rEPIC04E-HK )

Fundación EPIC100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Coronary Artery Disease Ischemic Heart Disease

Interventions

Essential proDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Princess Margaret Hospital

Lai Chi Kok, Hong Kong

RECRUITING

Outcomes

Primary Outcomes

Safety Endpoint. Freedom from Target Lesion Failure

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).

Time frame: 12 months

Secondary Outcomes

Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)

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

Time frame: 12 months

Freedom from Balloon rupture

Time frame: During PCI

Freedom from Hypotube rupture

Time frame: During PCI

Freedom from Complicated withdrawal

Time frame: During PCI

Freedom from Coronary perforation

Time frame: During PCI

Freedom from Coronary dissection >C

Freedom from Coronary dissection \>C

Time frame: During PCI

Freedom from No reflow

Central Contacts

FUNDACION EPIC

CONTACT

0034987225638 iepic@fundacionepic.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.