Observing the safety and effectiveness of a new stent for coronary artery disease
Feasibility of CRE8 Polymer-free Amphilimus-eluting sTEnt in Patients With Diffuse Long Lesions (CREATE Trial): Prospective, Observational Study
This study is testing a new type of stent for people with coronary artery disease to see if it is safe and effective, especially for those with longer heart artery blockages.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 19 Years to 90 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Yongin, Gyeonggi-do) |
| Trial ID | NCT05658250 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of the Cre8 and Cre8 evo stents in patients with ischemic heart disease who have long coronary lesions measuring over 30 mm. A total of 300 patients will be monitored to assess the prognosis of these stents in a real-world setting. The study will also include a sub-analysis to examine stent expansion using optical coherence tomography (OCT) for very long stents measuring 46 mm. Participants will be followed to gather data on outcomes related to their coronary artery disease treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with clinical evidence of coronary artery disease and coronary artery lesions of 30 mm or more.
Not a fit: Patients with a life expectancy of less than one year or those with known hypersensitivity to certain antiplatelet medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of a new-generation stent, potentially improving treatment options for patients with long coronary lesions.
How similar studies have performed: While this approach is observational, similar studies evaluating new stent technologies have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Yongin, Gyeonggi-do
- Yongin Severance Hospital — Yongin, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: deok kyu CHO, MD
- Email: CHODK123@yuhs.ac
- Phone: +82-31-5189-8755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.