Sequent Extended Study (rEpic06)

April 21, 2026 updated by: Fundación EPIC

Sequent Please Neo Extended Post-Market Clinical Follow-up Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

2028

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Alava, Spain, 01009
        • Recruiting
        • Hospital Universitario de Araba
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario de Alicante Dr.Balmis
      • Badajoz, Spain, 06080
        • Recruiting
        • Hospital Universitario de Badajoz
      • Badalona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
      • Barakaldo, Spain, 48903
        • Recruiting
        • Hospital Universitario de Cruces
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de La Santa Creu Y Sant Pau
      • Cadiz, Spain, 11009
        • Recruiting
        • Hospital Universitario Puerta del Mar
      • Castelló, Spain, 12004
        • Recruiting
        • Hospital General Universitari de Castelló
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital Universitario de Ciudad Real
      • Cáceres, Spain, 10003
        • Recruiting
        • Hospital Universitario San Pedro de Alcantara
      • Elche, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
      • Gijón, Spain, 33394
        • Recruiting
        • Hospital Universitario de Cabueñes
      • Girona, Spain, 17007
        • Recruiting
        • Hospital Universitari Dr. Josep Trueta
      • Huelva, Spain, 21005
        • Recruiting
        • Hospital Universitario Juan Ramon Jimenez
      • Jaén, Spain, 23007
        • Recruiting
        • Hospital Universitario de Jaén
      • León, Spain, 240801
        • Recruiting
        • Hospital Universitario de Leon
      • Lugo, Spain, 27003
        • Recruiting
        • Hospital Universitario Lucus Agustí
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga
      • Mérida, Spain, 06800
        • Recruiting
        • Hospital de Merida
      • Puerto Real, Spain, 11510
        • Recruiting
        • Hospital Universitario Puerto Real
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Clínico Universitario de Salamanca
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Toledo, Spain, 45007
        • Recruiting
        • Hospital General Universitario de Toledo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with Sequent Please Neo according to routine hospital practice and following instructions for use.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Artery Disease (CAD)
Device: Sequent Please Neo
Patients in whom treatment with (Sequent Please Neo) has been attempted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)
Time Frame: 12 months
Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from MACE in the subgroup of Lesions In-stent Restenosis
Time Frame: 12 months
Freedom from MACE in the subgroup of Lesions In-stent Restenosis
12 months
Freedom from MACE in the subgroup of Native vessel lesions
Time Frame: 12 months
Freedom from MACE in the subgroup of Native vessel lesions
12 months
Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
Time Frame: 12 months
Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
12 months
Procedural success
Time Frame: Immediately after PCI (Percutaneous Coronary Intervention)
Procedural success ( Residual stenosis <30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure)
Immediately after PCI (Percutaneous Coronary Intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 26, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rEpic06- SEQUENT EXTENDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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