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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT03074305
Eligibility Criteria:
Inclusion Criteria:
* Subject age 19-85 years old
* Patients with BRS ISR and presented with angina symptom or objective sign of inducible myocardial ischemia (one of the followings)
1. Visual stenosis ≥50% in ISR segment with typical angina symptom (CCS class ≥II) or positive non-invasive stress tests
2. ISR lesion with fractional flow reserve (FFR) ≤0.80
3. Visual stenosis ≥70% in ISR segment (in the absence of above 2 components)
* Patients with BRS ISR which can be treated by DEB angioplasty or second generation DES implantation
Exclusion Criteria:
* Cardiogenic shock (Killip class IV) already at presentation or the completion of culprit PCI
* Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus
* Patients with active bleeding or history of gastrointestinal or genitourinary major bleeding within 3-month
* Chronic kidney disease (serum creatinine ≥2.0mg/dL or estimated glomerular filtration rate \<30ml/min)
* Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
* In-segment edge restenosis without definite involvement of previous BRS edge
* Unwillingness or inability to comply with the procedures described in this protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT03074305
Study Brief:
Protocol Section:
NCT03074305