Sequent Extended Study

Last updated: March 3, 2025
Sponsor: Fundación EPIC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Myocardial Ischemia

Hypercholesterolemia

Treatment

Sequent Please Neo

Clinical Study ID

NCT05788432
rEpic06- SEQUENT EXTENDED
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients treated with Sequent please neo according to routine hospital practice andfollowing instruction for use.

  • Informed Consent Signed.

Exclusion

Exclusion Criteria:

  • Patient life expectancy less than 12 months.

  • Contraindication for antiplatelet therapy.

  • Not meet inclusion criteria.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Sequent Please Neo
Phase:
Study Start date:
March 28, 2023
Estimated Completion Date:
July 01, 2025

Study 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.

Connect with a study center

  • Hospital Universitario de Araba

    Alava, 01009
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante Dr.Balmis

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital Universitario de Badajoz

    Badajoz, 06080
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Baracaldo, 48903
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11009
    Spain

    Active - Recruiting

  • Hospital Universitario de Ciudad Real

    Ciudad Real, 13005
    Spain

    Active - Recruiting

  • Hospital Universitario San Pedro de Alcantara

    Cáceres, 10003
    Spain

    Active - Recruiting

  • Hospital Universitari Dr. Josep Trueta

    Gerona, 17007
    Spain

    Active - Recruiting

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005
    Spain

    Active - Recruiting

  • Hospital Universitario de Jaen

    Jaén, 23007
    Spain

    Active - Recruiting

  • Hospital Universitario de Leon

    León, 240801
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Agusti

    Lugo, 27003
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de La Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital de Mérida

    Mérida, 06800
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

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