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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT05493904
Eligibility Criteria:
Inclusion Criteria:
1. Patients \>18 years old
2. Patients with stable or unstable angina and complex coronary lesions\*
3. Patients who were indicated revascularization
* Diameter stenosis \>90% by angiography
* Diameter stenosis with 50\~90% with pre-interventional FFR ≤0.80
4. Patients who underwent implantation of 2nd generation drug-eluting stent
* Definitions of complex coronary lesions
1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
2. Chronic total occlusion (≥3 months) as target lesion
3. PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
4. Long coronary lesions (implanted stent ≥38 mm in length)
5. Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)
6. Multiple stents needed (≥3 more stent per patient)
7. In-stent restenosis lesion as target lesion
8. Severely calcified lesion (encircling calcium in angiography)
9. Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion
Exclusion Criteria:
1. Target lesions not amenable for PCI by operators' decision
2. Cardiogenic shock (Killip class IV) at presentation
3. Less than TIMI 3 flow of target vessel after index procedure
4. Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
5. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
6. Renal insufficiency such that an additional contrast medium would be harmful for patient
7. Recent ST-segment elevation myocardial infarction (STEMI)
8. Inability to receive adenosine or nicorandil injection
9. Pregnancy or breast feeding
10. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
11. Unwillingness or inability to comply with the procedures described in this protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05493904
Study Brief:
Protocol Section:
NCT05493904