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 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 12:57 AM
NCT ID:
NCT07114393
Eligibility Criteria:
Inclusion Criteria:
All patients above the age of 18, included in the Netherlands Heart Registration (NHR) quality database after receiving PCI in complex coronary lesions, will be included in the analyses of this project.
Complex lesions include:
Left main A stenosis of \>50% and/or a FFR ≤ 0.80 and iFR ≤ 0.89 in the left main.
Severely calcified lesion Defined as use of calcium modification therapy (e.g. cutting balloon, scoring balloon, rotablation, orbital atherectomy, intravascular lithotripsy).
Chronic total occlusion
Coronary CTO is defined as an obstruction of the coronary artery with the following classic lesion characteristics:
* TIMI flow 0
* Absence of contrast stasis at the site of the proximal capillaries
* Presence of collateral vessels
* Estimated occlusion duration of at least 3 months.
Ostial lesion Lesion at the origin (within 5 mm) of a major coronary vessel (LM, LAD, RCX and RCA).
Severely calcified lesion. Long lesion A vessel treated with one or multiple stents with a total stent length of ≥38 mm is considered a long lesion.
Bifurcation (true) A coronary artery narrowing occurring adjacent to, and/or involving, the origin of a significant side branch ≥ 2.5mm. Only true bifurcation will be included, i.e. medina 1,1,1/1,0,1/0,1,1.
In-stent restenosis A reduction ≥50% of the luminal diameter within the previously stented segment or the vessel segments 5 mm proximal and distal to the stent (the "stent edges"), as assessed by coronary angiography.
Exclusion Criteria:
* Non complex PCI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07114393
Study Brief:
Protocol Section:
NCT07114393