RECRUITINGOBSERVATIONAL
Coroflex® ISAR NEO PMCF Study
Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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
- willing to sign a consent form signed
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Locations (20)
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Centre Hospitalier Ajaccio
Ajaccio, France
CH Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
University Hospital Center of Caen
Caen, France
Hôpital Albert Schweitzer
Colmar, France
Hospitalario Universitario (CHU) de Lille
Lille, France
APHP -Hôpital Lariboisière
Paris, France
Institut Arnault Tzanck
Saint-Laurent-du-Var, France
Hospital Universitario A Coruña
A Coruña, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital Universitari Germans Trias I Pujol
Badalona, Spain
Hospital Universitario de Cruces
Barakaldo, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall D Hebron
Barcelona, Spain
Hospital Universitario San Pedro de Alcantara
Cáceres, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain
Hospital Universitario de Leon
León, Spain
Hospital Universitario Lucus Agusti
Lugo, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain