IonMAN Trial- First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System (NCT05364697) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
IonMAN Trial- First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
Brazil, Israel60 participantsStarted 2022-08-30
Plain-language summary
This is a prospective, multi-center, single-arm, open-label, First in Human clinical trial to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years.
✓. Patient with an indication for PCI including NSTEMI (biomarkers have peaked or are falling), angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80, Pd/Pa≤0.91or iFR, RFR, DFR, DPR≤0.89 must be present).
✓. Non-target vessel PCIs are allowed if performed \>30 days prior to index procedure.
✓. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
✓. Staged procedures are allowed as long as the IoNIR stent is implanted in the last procedure and at least 30 days have elapsed between the previous procedure and the IoNIR PCI.
✓. One de novo target lesion ONLY may be treated (more than one lesion separated by less than 5 mm are considered one lesion).
✓. Target lesion must be in a major native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.0 mm and lesion length of up to 28 mm, and appropriate size IoNIR stent is available
Exclusion criteria
✕. ST Segment Elevation MI within past 30 days.
✕. NSTEMI with biomarkers that have not peaked.
✕. Significant valvular disease or planned valvular intervention.
✕. PCI within the 30 days preceding the baseline procedure.