Coronary Artery Disease (CAD), Ischemic Heart Disease
Conditions
Keywords
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Paclitaxel eluting 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 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.
Interventions
DRUGEssential pro
Patients in whom treatment with (Essential Pro) 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 Essential Pro 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 | 12 months | 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 |
|---|---|---|
| Efficacy Endpoint. Freedom from Target Lesion Failure (TLF) | 12 months | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). |
| Freedom from Balloon rupture | During percutaneous coronary intervention (PCI) | Freedom from Balloon rupture |
| Freedom from Hypotube rupture | During PCI | Freedom from Hypotube rupture |
| Freedom from Complicated withdrawal | During PCI | Freedom from Complicated withdrawal |
| Freedom from Coronary perforation | During PCI | Freedom from Coronary perforation |
| 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 |
Countries
Spain
Outcome results
None listed