SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

Launched by FUNDACIÓN EPIC · Nov 8, 2022

Keywords

ClinConnect Summary

The SUPRAFLEX CRUZ PMCF Study is a clinical trial designed to evaluate the safety and effectiveness of a medical device called the SUPRAFLEX CRUZ stent in patients with coronary artery disease (CAD) and ischemic heart disease. This study will include patients who have blockages in multiple major coronary arteries and require more than one stent to treat their condition. By closely monitoring these patients after their treatment, the researchers aim to gather important information on how well this stent works and whether it meets the necessary medical standards.

To participate in this trial, patients must be at least 18 years old and have multivessel coronary artery disease, meaning they have blockages in more than one major coronary artery. They must also be treated with the SUPRAFLEX CRUZ stent according to standard hospital practices. Participants will need to sign an informed consent form, which means they agree to take part in the study after understanding what it involves. It's important to note that individuals with certain health issues, such as a life expectancy of less than 12 months or those who cannot take antiplatelet medications, will not be eligible for this trial. Participants can expect regular follow-ups to assess their health and the performance of the stent over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 18 years old and;
• • Patients treated with SUPRAFLEX CRUZ according to routine hospital practice and following instructions for use
• • Patients with multivessel coronary artery disease (understood as that which affects more than one territory of the major epicardial coronary arteries - anterior descending, circumflex, right coronary artery) who is treated with more than 1 stent under study in lesions located in more than 1 of the aforementioned arteries.
• • Substudy: Patients with Ejection Fraction \<45% by Echocardiography
• • Informed consent signed
• Exclusion Criteria:
• • Not meet inclusion criteria
• • Contraindication for antiplatelet treatment
• • Patient life expectancy less than 12 months