Coroflex® ISAR NEO PMCF Study (rEPIC07)

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: Recruiting
• Conditions: Ischemic Heart Disease; Coronary Artery Disease (CAD)
• Intervention / Treatment: Device: Coroflex® ISAR NEO coronary stent system

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: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: koldobika García San Román, MD, PhD; Phone Number: 0034696704643; Email: koldobikags@hotmail.com
• Study Contact Backup: Name: FUNDACION EPIC; Phone Number: 0034987876135; Email: iepic@fundacionepic.org

Study Locations

• Spain
  • 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
  • Coruña, Spain, 15006
    • Recruiting
    • Hospital Universitario A Coruña
  • Cáceres, Spain, 10003
    • Recruiting
    • Hospital Universitario San Pedro de Alcántara
  • Huelva, Spain, 21005
    • Recruiting
    • Hospital Universitario Juan Ramon Jimenez
  • León, Spain, 24071
    • Recruiting
    • Hospital Universitario de Leon
  • Lugo, Spain, 27003
    • Recruiting
    • Hospital Universitario Lucus Agusti
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Clínico Universitario Lozano Blesa

Participation Criteria

Eligibility Criteria

• 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 with contraindications or hypersensitivity to sirolimus.
• Patients with a life expectancy of less than 2 years.
• Patients included in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Complicated withdrawal	Freedom from Complicated withdrawal	During PCI
Freedom from Coronary perforation	Freedom from Coronary perforation	During PCI
Freedom from Coronary dissection >C	Freedom from Coronary dissection >C	During PCI
Freedom from No reflow	Freedom from No reflow	During PCI
Freedom from Coronary thrombosis	Freedom from Coronary thrombosis	During PCI
Freedom from Hypotube rupture	Freedom from Hypotube rupture	During PCI
Freedom from Accidental dislodgement of the stent	Freedom from Accidental dislodgement of the stent	During percutaneous coronary intervention (PCI)
Freedom from Balloon rupture	Freedom from Balloon rupture	During PCI

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4242.
• 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. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096.
• 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.
• 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 record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Drug Eluting Stent; MDR (Medical Device Regulations); PMCF (Post-Market Clinical Follow-up)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID 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