Coroflex® ISAR NEO PMCF Study
rEPIC07
Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
1 other identifier
observational
3,000
2 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
August 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
May 1, 2026
April 1, 2026
3.5 years
January 16, 2023
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
Coronary Artery Disease (CAD) and high risk of bleeding
Coronary Artery Disease (CAD)
Interventions
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Eligibility Criteria
Patients treated with Coroflex® ISAR NEO coronary stent system according to routine hospital practice and following instructions for use
You may qualify if:
- 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
You may not qualify if:
- Patients with express refusal by the patient to participate in the study.
- Patients pregnant women and lactating women.
- Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
- Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated
- Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
- Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent
- Patients with known sensitivity to contrast agents who cannot be premedicated.
- Patients with contraindications or hypersensitivity to sirolimus
- Patients with a life expectancy of less than 2 years
- Patients included in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación EPIClead
Study Sites (22)
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
Hôpital Albert Schweitzer
Colmar, France
Hospitalario Universitario (CHU) de Lille
Lille, 59000, France
APHP -Hôpital Lariboisière
Paris, 75010, France
Institut Arnault Tzanck
Saint-Laurent-du-Var, 06700, 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
Related Publications (4)
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.
PMID: 31116395BACKGROUNDNeumann 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. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096. doi: 10.1093/eurheartj/ehz507.
PMID: 30165437BACKGROUNDKnuuti 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.
PMID: 31504439BACKGROUNDRuiz-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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2023
First Posted
January 26, 2023
Study Start
August 4, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04