NAVISCORE Post-Market Clinical Follow-up Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Fundación EPIC
- Enrollment
- 54
- Locations
- 7
- Primary Endpoint
- Safety Endpoint. Freedom from Target Lesion Failure
- Status
- Completed
- Last Updated
- 2 years 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 Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)(7 days)
- Freedom from Coronary perforation(During PCI (Percutaneous Coronary Intervention))
- Freedom from Hypotube rupture(During PCI (Percutaneous Coronary Intervention))
- Freedom from Complicated withdrawal(During PCI (Percutaneous Coronary Intervention))
- Freedom from Balloon rupture(During PCI (Percutaneous Coronary Intervention))
- Freedom from Coronary dissection >C(During PCI (Percutaneous Coronary Intervention))
- Freedom from Coronary thrombosis(During PCI (Percutaneous Coronary Intervention))
- Freedom from No reflow(During PCI (Percutaneous Coronary Intervention))