Coronary Artery Disease (CAD), Ischemic Heart Disease
Conditions
Keywords
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Drug Eluting Stent
Brief summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Angiolite sirolimus eluting stent to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Angiolite sirolimus eluting stent.
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 Angiolite Sirolimus Eluting Stent 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
DEVICEANGIOLITE
Patients in whom treatment with ANGIOLITE 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
* Patients treated with ANGIOLITE 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, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Accidental dislodgement of the stent | During percutaneous coronary intervention (PCI) | Freedom from Accidental dislodgement of the stent |
| 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 |
| Efficacy 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). |
| 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