Coroflex® ISAR NEO PMCF Study

Recruiting

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

• Registration Number: NCT05698732
• Lead Sponsor: Fundación EPIC

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.

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 Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-26
• Study Start: 2023-08-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease (CAD)	Coroflex® ISAR NEO coronary stent system	-
Coronary Artery Disease (CAD) and high risk of bleeding	Coroflex® ISAR NEO coronary stent system	-

Primary Outcome Measures

Name	Time	Method
Efficacy Endpoint. Freedom fromTarget Lesion Failure	7 days	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Safety Endpoint. Freedom from Target Lesion Failure	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)

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario de Badajoz; 🇪🇸 Badajoz, Spain

Hospital Universitari Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Hospital Universitario de Cruces; 🇪🇸 Barakaldo, Spain

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario A Coruña; 🇪🇸 Coruña, Spain

Hospital Universitario Juan Ramon Jimenez; 🇪🇸 Huelva, Spain

Hospital Universitario de Leon; 🇪🇸 León, Spain

Hospital Universitario San Pedro de Alcantara; 🇪🇸 Cáceres, Spain

Hospital Universitario Lucus Agusti; 🇪🇸 Lugo, Spain

Hospital Clinico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain