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NCT05698732Recruiting

Coroflex® ISAR NEO PMCF Study

Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
3000 (estimated)
First submitted
16 Jan 2023
Start date
4 Aug 2023
Primary completion date
1 Feb 2027
Lead sponsor
Fundación EPIC
NCT number
NCT05698732

What you commit to

  • Study type: Observational
  • Planned participants: 3000
  • From 4 Aug 2023 to the primary completion date, 1 Feb 2027
  • 26 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent

Other illness

  • Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
  • Patients with contraindications or hypersensitivity to sirolimus

Lab values

  • Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated

Other

  • Patients with express refusal by the patient to participate in the study.
  • Patients pregnant women and lactating women.
  • Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
  • Patients with known sensitivity to contrast agents who cannot be premedicated.
  • Patients with a life expectancy of less than 2 years
  • Patients included in other clinical trials

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Universitario de Badajoz
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BadajozSpainRecruiting
Hospital Universitari Germans Trias i Pujol
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BadalonaSpainRecruiting
Hospital Universitario de Cruces
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BarakaldoSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario San Pedro de Alcántara
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CáceresSpainRecruiting
Hospital General Universitario de Ciudad Real
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Ciudad RealSpainRecruiting
Hospital Universitario Juan Ramon Jimenez
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HuelvaSpainRecruiting
Hospital Universitario De Leon
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LeónSpainRecruiting
Hospital Universitario Lucus Agusti
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LugoSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Hospital Regional Universitario de Malaga
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MálagaSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting
Centre Hospitalier du Pays d AIX
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Aix-en-ProvenceFranceRecruiting
Centre Hospitalier Ajaccio
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AjaccioFranceRecruiting
CH Polyclinique Bordeaux Nord Aquitaine
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BordeauxFranceRecruiting
University Hospital Center of Caen
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CaenFranceRecruiting
Hôpital Albert Schweitzer
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ColmarFranceRecruiting
Hospitalario Universitario (CHU) de Lille
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LilleFranceRecruiting
Aphp-Hopital Lariboisiere
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ParisFranceRecruiting
Clinique Saint-Hilaire
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RouenFranceRecruiting
Institut Arnault Tzanck
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Saint-Laurent-du-VarFranceRecruiting
Centre Hospitalier Universitaire (CHU) de Toulouse
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ToulouseFranceRecruiting
King's Mill Hospital, Sherwood Forest Hospitals
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Sutton in AshfieldUnited KingdomRecruiting
Royal Albert Edward Infirmary
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WiganUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.