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Recruiting NCT05788432

Sequent Extended Study

Conditions: Coronary Artery Disease Ischemic Heart Disease

Sponsor: Fundación EPIC

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
Inclusion Criteria: * Patients treated with Sequent please neo according to routine hospital practice and following instruction for use. * Informed Consent Signed. Exclusion Criteria: * Patient life expectancy less than 12 months. * Contraindication for antiplatelet therapy. * Not meet inclusion criteria.
Interventions
Sequent Please Neo
DEVICE
Locations 27
Spain (27)
Hospital Universitario de Araba
Alava
Hospital General Universitario de Alicante Dr.Balmis
Alicante
Hospital Universitario de Badajoz
Badajoz
Hospital Universitari Germans Trias I Pujol
Badalona
Hospital Universitario de Cruces
Barakaldo
Hospital de La Santa Creu Y Sant Pau
Barcelona
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario San Pedro de Alcantara
Cáceres
Hospital Universitario Puerta Del Mar
Cadiz
Hospital General Universitari de Castelló
Castelló
Hospital Universitario de Ciudad Real
Ciudad Real
Hospital General Universitario de Elche
Elche
Hospital Universitario de Cabueñes
Gijón
Hospital Universitari Dr. Josep Trueta
Girona
Hospital Universitario Juan Ramon Jimenez
Huelva
Hospital Universitario de Jaen
Jaén
Hospital Universitario de Leon
León
Hospital Universitario Lucus Agusti
Lugo
Hospital Universitario de La Princesa
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Regional Universitario de Malaga
Málaga
Hospital Universitario Virgen de La Victoria
Málaga
Hospital de Mérida
Mérida
Hospital Universitario Puerto Real
Puerto Real
Hospital Clinico Universitario de Salamanca
Salamanca
Hospital Universitario Virgen Del Rocio
Seville
Hospital General Universitario de Toledo
Toledo
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.03.2023
Completion date
01.07.2026
Registry ID
NCT05788432
Source
clinicaltrials.gov
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