Coronary Artery Disease (CAD)rEPIC07NCT05698732
Coroflex® ISAR NEO PMCF Study
An observational study of Coronary Artery Disease (CAD) and Ischemic Heart Disease, run by Fundación EPIC at 26 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Ischemic Heart Disease
- What is being tested?
- Coroflex® ISAR NEO coronary stent system
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 26 sitesin 3 countries
- Study dates
- 4 Aug 2023to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with Coroflex® ISAR NEO coronary stent system according to routine hospital practice and following instructions for use
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
26 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 3 countries
Spain14 sites, 14 recruiting
- Recruiting
Hospital Universitario A Coruña
A Coruña, 15006
- Recruiting
Hospital Universitario de Badajoz
Badajoz, 06080
- Recruiting
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
- Recruiting
Hospital Universitario de Cruces
Barakaldo, 48903
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
- Recruiting
Hospital Universitari Vall D Hebron
Barcelona, 08035
- Recruiting
Hospital Universitario San Pedro de Alcantara
Cáceres, 10003
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
- Recruiting
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
- Recruiting
Hospital Universitario de Leon
León, 24071
- Recruiting
Hospital Universitario Lucus Agusti
Lugo, 27003
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, 29010
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
France10 sites, 10 recruiting
- Recruiting
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13100
- Recruiting
Centre Hospitalier Ajaccio
Ajaccio, 20090
- Recruiting
CH Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
- Recruiting
University Hospital Center of Caen
Caen, 14000
- Recruiting
Hôpital Albert Schweitzer
Colmar
- Recruiting
Hospitalario Universitario (CHU) de Lille
Lille, 59000
- Recruiting
APHP -Hôpital Lariboisière
Paris, 75010
- Recruiting
Clinique Saint-Hilaire
Rouen
- Recruiting
Institut Arnault Tzanck
Saint-Laurent-du-Var, 06700
- Recruiting
Centre hospitalier universitaire (CHU) de Toulouse
Toulouse, 31059
United Kingdom2 sites, 2 recruiting
- Recruiting
King's Mill Hospital, Sherwood Forest Hospitals
Sutton in Ashfield
- Recruiting
Royal Albert Edward Infirmary
Wigan
About this study
Official title: Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
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.
Read the detailed description
The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World 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.
- Being tested
- Coroflex® ISAR NEO coronary stent system
- Keywords
- MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Drug Eluting Stent
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coroflex® ISAR NEO coronary stent systemDevice
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease (CAD) and high risk of bleeding | Not described Receives: Device: Coroflex® ISAR NEO coronary stent system | |
| Coronary Artery Disease (CAD) | Not described Receives: Device: Coroflex® ISAR NEO coronary stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 7 days
Secondary outcomes (8)
Freedom from Accidental dislodgement of the stent
Freedom from Accidental dislodgement of the stent
Measured: During percutaneous coronary intervention (PCI)
Freedom from Balloon rupture
Freedom from Balloon rupture
Measured: During PCI
Freedom from Hypotube rupture
Freedom from Hypotube rupture
Measured: During PCI
Freedom from Complicated withdrawal
Freedom from Complicated withdrawal
Measured: During PCI
Freedom from Coronary perforation
Freedom from Coronary perforation
Measured: During PCI
Freedom from Coronary dissection >C
Freedom from Coronary dissection >C
Measured: During PCI
Freedom from No reflow
Freedom from No reflow
Measured: During PCI
Freedom from Coronary thrombosis
Freedom from Coronary thrombosis
Measured: During PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start4 Aug 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698732
- Sponsor's protocol ID
- Coroflex® ISAR NEO PMCF Study
- Acronym
- rEPIC07
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31116395Neumann 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.
PubMed 30165437Knuuti 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.
PubMed 31504439Ruiz-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 at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT05698732
- Acronym / sponsor ID
- rEPIC07 / Coroflex® ISAR NEO PMCF Study
- Keywords
- MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Drug Eluting Stent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) and high risk of bleeding | – | Device: Coroflex® ISAR NEO coronary stent system |
| Coronary Artery Disease (CAD) | – | Device: Coroflex® ISAR NEO coronary stent system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with Coroflex® ISAR NEO coronary stent system according to routine hospital practice and following instructions for use
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coroflex® ISAR NEO coronary stent systemPatients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted | Device | Coronary Artery Disease (CAD), Coronary Artery Disease (CAD) and high risk of bleeding |
Primary outcome
Safety Endpoint. Freedom from Target Lesion Failure
Time frame: 7 days
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)
Efficacy Endpoint. Freedom fromTarget Lesion Failure
Time frame: 7 days
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
8 secondary outcomes
Freedom from Accidental dislodgement of the stent
Time frame: During percutaneous coronary intervention (PCI)
Freedom from Balloon rupture
Time frame: During PCI
Freedom from Hypotube rupture
Time frame: During PCI
Freedom from Complicated withdrawal
Time frame: During PCI
Freedom from Coronary perforation
Time frame: During PCI
Freedom from Coronary dissection >C
Time frame: During PCI
Freedom from No reflow
Time frame: During PCI
Freedom from Coronary thrombosis
Time frame: During PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 31116395Urban 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.
- Background: PubMed 30165437Neumann 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.
- Background: PubMed 31504439Knuuti 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.
- BackgroundRuiz-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD) and Ischemic Heart Disease, run by Fundación EPIC at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Spain, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact koldobika García San Román, MD, PhD (0034696704643, koldobikags@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint. Freedom from Target Lesion Failure (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05698732, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.