Coronary Artery Disease (CAD), Ischemic Heart Disease
Conditions
Keywords
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Coronary microcatheter
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.
Interventions
DEVICENavitian
Patients in whom treatment with (Navitian) has been attempted
Sponsors
Fundación EPIC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint. Freedom fromTarget Lesion Failure | 7 days | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Device rupture | During percutaneous coronary intervention (PCI) | Freedom from Device rupture |
| Freedom from Kinking | During PCI | Freedom from Kinking |
| Freedom from Complicated withdrawal | During PCI | Freedom from Complicated withdrawal |
| Efficacy Endpoint. Freedom from Target Lesion Failure | 7 days | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). |
| 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 |
| Freedom from Coronary perforation | During PCI | Freedom from Coronary perforation |
Countries
Portugal, Spain
Outcome results
None listed