Coronary Artery Disease (CAD), 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 Xperience Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Xperience 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 Xperience 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
DEVICEXperience Pro
Patients in whom treatment with (Xperience 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 Xperience 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 | 7 days | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction and and new Target Lesion Revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Efficacy Endpoint. Freedom from Target Lesion Failure | 7 days | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and 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
Spain
Outcome results
None listed