Coroflex® ISAR NEO PMCF Study (rEPIC07)

September 10, 2026 updated by: Fundación EPIC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France, 13100
        • Recruiting
        • Centre Hospitalier du Pays d'Aix
      • Ajaccio, France, 20090
        • Recruiting
        • Centre Hospitalier Ajaccio
      • Bordeaux, France, 33300
        • Recruiting
        • CH Polyclinique Bordeaux Nord Aquitaine
      • Caen, France, 14000
        • Recruiting
        • University Hospital Center of Caen
      • Colmar, France
        • Recruiting
        • Hôpital Albert Schweitzer
      • Lille, France, 59000
        • Recruiting
        • Hospitalario Universitario (CHU) de Lille
      • Paris, France, 75010
        • Recruiting
        • APHP -Hôpital Lariboisière
      • Rouen, France
        • Recruiting
        • Clinique Saint-Hilaire
      • Saint-Laurent-du-Var, France, 06700
        • Recruiting
        • Institut Arnault Tzanck
      • Toulouse, France, 31059
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Toulouse
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Hospital Universitario A Coruna
      • 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, 08025
        • Recruiting
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall D Hebron
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario de Ciudad Real
      • Cáceres, Spain, 10003
        • Recruiting
        • Hospital Universitario San Pedro de Alcantara
      • Huelva, Spain, 21005
        • Recruiting
        • Hospital Universitario Juan Ramón Jiménez
      • León, Spain, 24071
        • Recruiting
        • Hospital Universitario de Leon
      • Lugo, Spain, 27003
        • Recruiting
        • Hospital Universitario Lucus Agusti
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Málaga
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clínico Universitario Lozano Blesa
  • United Kingdom
      • Sutton in Ashfield, United Kingdom
        • Not yet recruiting
        • King's Mill Hospital, Sherwood Forest Hospitals
      • Wigan, United Kingdom
        • Recruiting
        • Royal Albert Edward Infirmary

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 Coroflex® ISAR NEO coronary stent system according to routine hospital practice and following instructions for use

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Coronary Artery Disease (CAD)
Device: Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Coronary Artery Disease (CAD) and high risk of bleeding
Device: Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
7 days
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).
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom from Complicated withdrawal
Time Frame: During PCI
Freedom from Complicated withdrawal
During PCI
Freedom from Coronary perforation
Time Frame: During PCI
Freedom from Coronary perforation
During PCI
Freedom from Coronary dissection >C
Time Frame: During PCI
Freedom from Coronary dissection >C
During PCI
Freedom from No reflow
Time Frame: During PCI
Freedom from No reflow
During PCI
Freedom from Coronary thrombosis
Time Frame: During PCI
Freedom from Coronary thrombosis
During PCI
Freedom from Hypotube rupture
Time Frame: During PCI
Freedom from Hypotube rupture
During PCI
Freedom from Accidental dislodgement of the stent
Time Frame: During percutaneous coronary intervention (PCI)
Freedom from Accidental dislodgement of the stent
During percutaneous coronary intervention (PCI)
Freedom from Balloon rupture
Time Frame: During PCI
Freedom from Balloon rupture
During PCI

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Coroflex® ISAR NEO PMCF Study

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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