Essential Pro Study ( rEPIC04E-HK )

Not yet recruiting

• Conditions: Coronary Artery Disease; Ischemic Heart Disease
• Interventions: Device: Essential pro

• Registration Number: NCT06631157
• Lead Sponsor: Fundación EPIC

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Study Start: 2024-11-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease (CAD)	Essential pro	-

Primary Outcome Measures

Name	Time	Method
Safety Endpoint. Freedom from Target Lesion Failure	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 Outcome Measures

Name	Time	Method
Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)	12 months	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Freedom from Balloon rupture	During PCI	Freedom from Balloon rupture
Freedom from Hypotube rupture	During PCI	Freedom from Hypotube rupture
Freedom from Complicated withdrawal	During PCI	Freedom from Complicated withdrawal
Freedom from Coronary perforation	During PCI	Freedom from Coronary perforation
Freedom from Coronary dissection >C	During PCI	Freedom from Coronary dissection \>C
Freedom from No reflow	During PCI	Freedom from No reflow
Freedom from Coronary thrombosis	During PCI	Freedom from Coronary thrombosis