Coronary Artery Disease (CAD), Ischemic Heart Disease
Conditions
Keywords
MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Drug Eluting Stent
Brief summary
International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.
Detailed description
The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system 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
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system 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
Coroflex® ISAR NEO is intended to be used for * Patients must be at least 18 years of age AND * The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND * Patients with Novo lesion length 2-4 mm AND * Informed consent signed
Exclusion criteria
* Patients with express refusal by the patient to participate in the study. * Patients pregnant women and lactating women. * Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4). * Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated * Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation * Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent * Patients with known sensitivity to contrast agents who cannot be premedicated. * Patients with contraindications or hypersensitivity to sirolimus * Patients with a life expectancy of less than 2 years * Patients included in other clinical trials
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) |
| 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). |
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 |
| 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
France, Spain, United Kingdom
Contacts
CONTACTkoldobika García San Román, MD, PhD
CONTACTFUNDACION EPIC
Outcome results
None listed