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 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT05915468
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or older
* Patients who have undergone PCI of at least one de-novo coronary lesion confirmed on coronary angiography using SELUTION SLR DEB, within 7 days prior to study registration.
* Vessel diameter must be ≥ 2.75 mm
* Bifurcation lesions: where main branch ≥ 2.75 mm and a DEB only strategy was applied in at least the main branch.
* Patients who give informed consent for participation in the study.
Exclusion Criteria:
* Patients with ST Elevation Myocardial Infarction (STEMI)
* Patients with cardiogenic shock.
* Patients who need urgent PCI following out of hospital cardiac arrest
* Patients with Left Main Stem or distal Left Main Stem bifurcation disease
* Patients with history of previous coronary revascularisation (PCI or CABG) prior to the baseline PCI
* Patients requiring calcium modification with rotational, orbital or laser atherectomy or intra-vascular lithotripsy (IVL)
* Patients with in-stent restenosis (ISR)
* Patients with Chronic Total Occlusions (CTO)
* Vessel diameter less than 2.75 mm
* Bifurcation lesion treated with stent (either main or side branch)
* Patients who have undergone cardiac transplant
* Patients with history of malignancy and life expectancy less than 12 months
* Patients who are pregnant or possibly pregnant.
* Patients have a known hypersensitivity or contraindication to Aspirin, Clopidogrel, Heparin or any other anticoagulation / antiplatelet therapy required for PCI, Sirolimus or contrast media.
* Patients scheduled to undergo elective surgery within 1-month post-index PCI.
* Patients who are currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this registry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05915468
Study Brief:
Protocol Section:
NCT05915468