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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT07004569
Eligibility Criteria:
Inclusion Criteria:
1. Subject age \>18.
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent.
3. Indication for a percutaneous coronary intervention (PCI) in native epicardial arteries involving left main coronary artery, including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction and ST-elevation myocardial infarction).
4. Target lesion must have a stenosis of \>50% and \<100% angiographically.
5. Target lesion much have an angiographic reference vessel diameter of 2.0-6.0 mm.
6. All lesions requiring PCI should be amendable for implantation of study stents.
Exclusion Criteria:
1. Known history of an allergic reaction or significant sensitivity to sirolimus or other analogue or derivative.
2. Known history of an allergic reaction or significant sensitivity to fluoroacrylate or its analogue or derivative.
3. Pregnant or breastfeeding woman.
4. Currently participating in another device study that has not completed the primary end point or that clinically interferes with the current study endpoints.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07004569
Study Brief:
Protocol Section:
NCT07004569