Coroflex® ISAR NEO PMCF Study

Launched by FUNDACIÓN EPIC · Jan 16, 2023

Keywords

ClinConnect Summary

The Coroflex® ISAR NEO PMCF Study is a clinical trial that aims to evaluate the safety and effectiveness of a specific type of coronary stent, called the Coroflex® ISAR NEO. This stent is used to treat patients with coronary artery disease, a condition where the blood vessels supplying the heart become narrowed. The study is open to adults aged 18 and older who meet certain health criteria, such as having a specific type of heart issue that can be treated with this stent. Participants will need to provide informed consent, meaning they agree to be part of the study after understanding what it involves.

If you join this study, you can expect to receive the Coroflex® ISAR NEO stent as part of your regular treatment for heart problems. The trial is actively recruiting participants across multiple centers, and it’s important to know that certain individuals, such as those who are pregnant, have specific heart emergencies, or who are involved in other clinical trials, cannot participate. This research will help ensure that the stent meets safety standards and regulations in Europe, ultimately benefiting patients like you in the future.

Gender

ALL

Eligibility criteria

• 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.