Essential Pro Post-Market Clinical Follow-up Study
Overview
- Phase
- Not Applicable
- Intervention
- Essential pro
- Conditions
- Coronary Artery Disease (CAD)
- Sponsor
- Fundación EPIC
- Enrollment
- 161
- Locations
- 7
- Primary Endpoint
- Safety Endpoint. Freedom from Target Lesion Failure
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
Multicenter, 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
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 Essential Pro 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Coronary Artery Disease (CAD)
Intervention: Essential pro
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Freedom from Coronary perforation(During PCI)
- Freedom from Hypotube rupture(During PCI)
- Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)(12 months)
- Freedom from No reflow(During PCI)
- Freedom from Balloon rupture(During percutaneous coronary intervention (PCI))
- Freedom from Complicated withdrawal(During PCI)
- Freedom from Coronary dissection >C(During PCI)
- Freedom from Coronary thrombosis(During PCI)