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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT06223633
Eligibility Criteria:
Inclusion Criteria:
* Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter
Exclusion Criteria:
* Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated.
* Patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the system (siloxane-based polyurethane, L-605 cobalt chromium alloy including tungsten and nickel).
* Lesions that cannot be reached or treated with the system.
* Lesions with threatened or abrupt closure during attempted pre-dilation prior to stent implantation.
* Risk of treatment-related occlusion of vital coronary artery side branches.
* Uncorrected bleeding disorders.
* Allergy to contrast media.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06223633
Study Brief:
Protocol Section:
NCT06223633