Navitian Post-Market Clinical Follow-up Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease (CAD)
- Sponsor
- Fundación EPIC
- Enrollment
- 102
- Locations
- 8
- Primary Endpoint
- Safety Endpoint. Freedom fromTarget Lesion Failure
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Navitian to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Navitian.
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 Navitian 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 Navitian 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 fromTarget Lesion Failure
Time Frame: 7 days
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Secondary Outcomes
- Efficacy Endpoint. Freedom from Target Lesion Failure(7 days)
- Freedom from Device rupture(During percutaneous coronary intervention (PCI))
- Freedom from Kinking(During PCI)
- Freedom from Coronary perforation(During PCI)
- Freedom from Complicated withdrawal(During PCI)
- Freedom from Coronary thrombosis(During PCI)
- Freedom from Coronary dissection >C(During PCI)
- Freedom from No reflow(During PCI)