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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04470934
Eligibility Criteria:
Inclusion Criteria:
* All common significant coronary lesions
* Target lesion length \>34mm need to be covered with at least 2 devices
* Patients eligible for this study must be at least 18 years of age
* The patient must fulfil the standard recommendations for percutaneous coronary intervention (PCI), based on the last ESC recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment
Exclusion Criteria:
* Intolerance to sirolimus
* Allergy to components of the coating
* Pregnancy and lactation
* Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
* Cardiogenic shock
* Risk of an intraluminal thrombus
* Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
* Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
* Severe allergy to contrast media
* Lesions which are untreatable with PCI or other interventional techniques
* Patients with an ejection fraction of \< 30 %
* Vascular reference diameter \< 2.00 mm
* Treatment of the left stem (first section of the left coronary artery)
* Indication for a bypass surgery
* Contraindication for whichever accompanying medication is necessary
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04470934
Study Brief:
Protocol Section:
NCT04470934