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:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT04971356
Eligibility Criteria:
Inclusion Criteria:
1. Patients with an indication for PCI due to acute coronary syndrome
2. All target lesions can be successful treatment of PCI with drug-coated balloon (DCB)
3. Patients who are able to complete the follow-up and compliant to the prescribed medication
Exclusion Criteria:
1. Under the age of 18 or Older than 80 years old
2. Unable to give informed consent
3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
4. Known contraindication to medications such as Heparin, antiplatelet drugs, or contrast.
5. Currently participating in another trial and not yet at its primary endpoint
6. Planned elective surgery
7. Concurrent medical condition with a life expectancy of less than 1 years
8. Previous intracranial haemorrhage
9. Need long-term oral anticoagulant therapy
10. Cardiogenic shock
11. Previous stent implantation 6 month
12. In-stent thrombosis
13. Target lesion located in surgical conduit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04971356
Study Brief:
Protocol Section:
NCT04971356