Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.
The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word 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
2,028
Patients in whom treatment with (Sequent Please Neo) has been attempted
Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)
Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)
Time frame: 12 months
Freedom from MACE in the subgroup of Lesions In-stent Restenosis
Freedom from MACE in the subgroup of Lesions In-stent Restenosis
Time frame: 12 months
Freedom from MACE in the subgroup of Native vessel lesions
Freedom from MACE in the subgroup of Native vessel lesions
Time frame: 12 months
Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
Time frame: 12 months
Procedural success
Procedural success ( Residual stenosis \<30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure)
Time frame: Immediately after PCI (Percutaneous Coronary Intervention)
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Hospital Universitario de Araba
Alava, Spain
RECRUITINGHospital General Universitario de Alicante Dr.Balmis
Alicante, Spain
RECRUITINGHospital Universitario de Badajoz
Badajoz, Spain
RECRUITINGHospital Universitari Germans Trias I Pujol
Badalona, Spain
RECRUITINGHospital Universitario de Cruces
Barakaldo, Spain
RECRUITINGHospital de La Santa Creu Y Sant Pau
Barcelona, Spain
RECRUITINGHospital Clinic de Barcelona
Barcelona, Spain
RECRUITINGHospital Universitario Puerta Del Mar
Cadiz, Spain
RECRUITINGHospital General Universitari de Castelló
Castelló, Spain
RECRUITINGHospital Universitario San Pedro de Alcantara
Cáceres, Spain
RECRUITING...and 17 more locations