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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT01031667
Eligibility Criteria:
Inclusion Criteria:
1. Patients treated with PCI with stent
2. Male or female over 20 years of age
3. Presence of at least one PCI target lesion(lesion length ≤26mm) with ≥50% diameter stenosis that can be covered with a single Endeavor Sprint stent(Medtronic)
4. Other PCI target lesions also should be treated with Endeavor Sprint stents
5. Presence of an intermediate non-PCI target lesion with luminal narrowing of ≥30% and ≤70% by visual estimation
6. Signed written informed consent to participate in the study
Exclusion Criteria:
1. Intermediate (non-PCI target) lesions that might provide difficulty for IVUS evaluation because of following reasons: heavy calcification (\>90° Arc), tortuous vessel with sever angulation, total occlusion, or bifurcation lesions
2. Previous PCI in the last 6 months
3. Previous CABG
4. Patients with AMI undergoing primary PCI or rescue PCI after thrombolysis
5. Cardiogenic shock
6. Inability to take adequate anti-platelet therapy
7. Thrombocytopenia (platelet count \<70 x 109/l)
8. Known hypersensitivity or contraindication to any of the following medications: Heparin, aspirin, clopidogrel, cilostazol, probucol, statin, contrast media\*
\*Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.
9. History of severe ventricular arrhythmia
10. Significant QTc prolongation (≥470 ms) on ECG
11. NYHA class III/IV heart failure or LV ejection fraction ≤35%
12. Familial hypercholesterolemia
13. Uncontrolled hypertriglyceridemia (\>400 mg/dL)
14. Chronic renal failure with serum creatinine level ≥2mg/dL
15. Severe liver disease or transaminase level ≥3 times the upper limit of normal.
16. Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01031667
Study Brief:
Protocol Section:
NCT01031667