Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Coronary balloon dilatation catheter
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.
Interventions
DEVICENaviscore
Patients in whom treatment with (Naviscore) has been attempted
Sponsors
Fundación EPIC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint. Freedom from Target Lesion Failure | 7 days | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Balloon rupture | During PCI (Percutaneous Coronary Intervention) | Freedom from Balloon rupture |
| Freedom from Hypotube rupture | During PCI (Percutaneous Coronary Intervention) | Freedom from Hypotube rupture ( partial or total fracture of the shaft of the device) |
| Freedom from Complicated withdrawal | During PCI (Percutaneous Coronary Intervention) | Freedom from Complicated withdrawal (difficult or impossible device retrieval that may or may not cause clinical complications) |
| Efficacy Endpoint. Freedom from Target Lesion Failure (TLF) | 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 (Percutaneous Coronary Intervention) | Freedom from Coronary dissection \>C according to the NHLBI Classification (National Heart, Lung, and Blood Institute) |
| Freedom from No reflow | During PCI (Percutaneous Coronary Intervention) | Freedom from No reflow (persistently slowed flow with residual stenosis \<30% and no flow-limiting dissection) |
| Freedom from Coronary thrombosis | During PCI (Percutaneous Coronary Intervention) | Freedom from Coronary thrombosis according to ARC-2 ( Academic Research Consortium-2) criteria |
| Freedom from Coronary perforation | During PCI (Percutaneous Coronary Intervention) | Freedom from Coronary perforation according to the modified Ellis classification |
Countries
Spain
Outcome results
None listed