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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT02776267
Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for clinically-indicated PCI of a de nove epicardial lesion, including those with chronic stable angina, ACS (defined as NSTEMI or ACS with negative cardiac enzymes) or in the setting of elective PCI.
* Indication for DES implantation
* Target lesion must have visually estimated stenosis ≥50% and one of the following: stenosis ≥70% or evidence of ischemia
* Strong preference for single stent coverage per lesion, but if unexpected clinically indicated second stent placement with overlap is needed, these patients will not be excluded from optical coherence tomographic follow-up
* Target lesion, if possible, should be predilated/pretreated
Exclusion Criteria:
* Age \>85 years
* Acute ST segment elevation MI (STEMI)
* Cardiogenic shock
* Known left ventricular ejection fraction \<30%
* Contraindication for dual antiplatelet therapy (DAPT) for at least 6-month duration
* Iodinated contrast allergy
* Renal impairment with serum creatinine \>2.0 mg/dL
* Anticipated medical non-compliance
* Life-expectancy \<12 months
* Chronic total occlusion (CTO) in the target vessel
* Bifurcation lesion requiring a two-stent strategy
* In-stent restenosis
* Severe lesion/segment angulation/tortuosity
* Severe vessel/lesion calcification
* Simultaneous PCI within the same or different vessel during the same procedure
* Lesion unsuitable for OCT (proximal lesions \<10 mm from ostium of left main or right coronary arteries)
* Lesion length \>18 mm
* Stent length \>24 mm
* Stent diameter ≤2.5 mm and \> 4.0 mm
* Unprotected left main coronary artery disease (≥50% diameter stenosis)
* \>1 lesion
* Planned use of 2 overlapping stents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02776267
Study Brief:
Protocol Section:
NCT02776267