Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT05656118
Eligibility Criteria:
Inclusion Criteria:
① Age ≥18 years old.
② Patients treated with Genoss® DCB in coronary artery In-stent restenosis (ISR) patients.
③ Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.
Exclusion Criteria:
* A woman who is pregnant, lactating, or planning a pregnancy. ② Patients who are scheduled for surgery requiring discontinuation of antiplatelet drugs within 12 months.
* Patients with life expectancy less than 1 year.
* Patients with cardiogenic shock and are predicted to have a low survival rate based on medical judgment.
* Patients participating in a medical device randomized controlled trials. ⑥ Patients who, in the judgment of the investigator, are not suitable for this clinical study or may increase the risks associated with participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05656118
Study Brief:
Protocol Section:
NCT05656118