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.
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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Safety Endpoint. Freedom from Target Lesion Failure
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)
Time frame: 7 days
Efficacy Endpoint. Freedom fromTarget Lesion Failure
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Time frame: 7 days
Freedom from Accidental dislodgement of the stent
Freedom from Accidental dislodgement of the stent
Time frame: During percutaneous coronary intervention (PCI)
Freedom from Balloon rupture
Freedom from Balloon rupture
Time frame: During PCI
Freedom from Hypotube rupture
Freedom from Hypotube rupture
Time frame: During PCI
Freedom from Complicated withdrawal
Freedom from Complicated withdrawal
Time frame: During PCI
Freedom from Coronary perforation
Freedom from Coronary perforation
Time frame: During PCI
Freedom from Coronary dissection >C
Freedom from Coronary dissection \>C
Time frame: During PCI
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Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Centre Hospitalier Ajaccio
Ajaccio, France
RECRUITINGCH Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
RECRUITINGUniversity Hospital Center of Caen
Caen, France
RECRUITINGHôpital Albert Schweitzer
Colmar, France
RECRUITINGHospitalario Universitario (CHU) de Lille
Lille, France
RECRUITINGAPHP -Hôpital Lariboisière
Paris, France
RECRUITINGClinique Saint-Hilaire
Rouen, France
RECRUITINGInstitut Arnault Tzanck
Saint-Laurent-du-Var, France
RECRUITINGCentre hospitalier universitaire (CHU) de Toulouse
Toulouse, France
RECRUITING...and 16 more locations
Freedom from No reflow
Freedom from No reflow
Time frame: During PCI
Freedom from Coronary thrombosis
Freedom from Coronary thrombosis
Time frame: During PCI