NCT05698732|RecruitingDMC
Coroflex® ISAR NEO PMCF Study
rEPIC07
Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
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rEPIC07
Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
Sponsor study identifier
observational
3,000
3 countries
26
Study Start
August 4, 2023
Actual (reported)Primary Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 16, 2023
Actual (reported)January 26, 2023
Actual (reported)August 4, 2023
Actual (reported)February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Safety Endpoint. Freedom from Target Lesion Failure
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR)
7 days
Efficacy Endpoint. Freedom fromTarget Lesion Failure
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
7 days
Freedom from Accidental dislodgement of the stent
During percutaneous coronary intervention (PCI)
Freedom from Balloon rupture
During PCI
Freedom from Hypotube rupture
During PCI
Freedom from Complicated withdrawal
During PCI
Freedom from Coronary perforation
During PCI
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients treated with Coroflex® ISAR NEO coronary stent system according to routine hospital practice and following instructions for use
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13100, France
Centre Hospitalier Ajaccio
Ajaccio, 20090, France
CH Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
University Hospital Center of Caen
Caen, 14000, France
Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J. 2019 Aug 14;40(31):2632-2653. doi: 10.1093/eurheartj/ehz372.
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
First Submitted
January 16, 2023
First Posted
January 26, 2023
Study Start
August 4, 2023
Actual (reported)Primary Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Hôpital Albert Schweitzer
Colmar, France
Hospitalario Universitario (CHU) de Lille
Lille, 59000, France
APHP -Hôpital Lariboisière
Paris, 75010, France
Clinique Saint-Hilaire
Rouen, France
Institut Arnault Tzanck
Saint-Laurent-du-Var, 06700, France
Centre hospitalier universitaire (CHU) de Toulouse
Toulouse, 31059, France
Hospital Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitario de Badajoz
Badajoz, 06080, Spain
Hospital Universitari Germans Trias I Pujol
Badalona, 08916, Spain
Hospital Universitario de Cruces
Barakaldo, 48903, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitari Vall D Hebron
Barcelona, 08035, Spain
Hospital Universitario San Pedro de Alcantara
Cáceres, 10003, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitario de Leon
León, 24071, Spain
Hospital Universitario Lucus Agusti
Lugo, 27003, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
King's Mill Hospital, Sherwood Forest Hospitals
Sutton in Ashfield, United Kingdom
Royal Albert Edward Infirmary
Wigan, United Kingdom
Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
Ruiz-Nodar JM, Ferreiro JL. Tratamiento antitrómbotico tras revascularización percutánea en pacientes con indicación crónica de anticoagulación oral. REC Interv Cardiol. 2019;1(1):41-50.
Study Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 21, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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