CREATE Trial, Prospective, Observational Study

Launched by YONSEI UNIVERSITY · Dec 19, 2022

Keywords

ClinConnect Summary

The CREATE Trial is a study looking at the safety and effectiveness of two types of heart stents, called the Cre8 stent and the Cre8 evo stent, in patients with coronary artery disease. This condition occurs when the blood vessels that supply the heart become narrowed or blocked, which can lead to serious heart problems. The study is currently recruiting participants aged 19 and older who have been diagnosed with coronary artery disease and have long lesions (30 mm or more) in their coronary arteries. It's important that participants are willing to provide written consent to join the study.

If you decide to participate, you'll be monitored to see how well these stents work and if they are safe for patients like you. However, there are some criteria that might prevent someone from joining, such as a life expectancy of less than one year or known allergies to certain heart medications. Overall, the CREATE Trial aims to gather important information to help improve treatment options for patients with ischemic heart disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 19 years of age or older
• • 2. Clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction)
• • 3. Coronary artery lesion length 30 mm or more
• • 4. Those who voluntarily agreed in writing to participate in this clinical study
• Exclusion Criteria:
• • 1. Remaining life expectancy is less than 1 year
• • 2. Subjects with known hypersensitivity or contraindication to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor
• • 3. In case the other researcher judges that it is inappropriate to participate in this study (pregnant women, the elderly, etc.)