Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Paclitaxel eluting coronary balloon dilatation catheter
Brief summary
Single center, 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
This study intends to analyze: * Device effectiveness (in its individual use, technical performance) and procedural effectiveness (technical outcome at the end of lesion treatment with the device under study and any other device being used). * Device safety (in its individual use, technical performance) and procedural safety (technical outcome at the end of lesion treatment with the device under study and any other device being used). * Clinical outcomes at the end of the procedure and during the specified follow-up period for each device. The follow-up timeframe is established based on the conditions of use and type of device being used, according to the requirements established by the relevant Notified Body.
Interventions
DEVICEEssential 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). 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 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
Hong Kong
Contacts
CONTACTFUNDACION EPIC
Outcome results
None listed