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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The IoNIR Ridaforolimus-Eluting Coronary Stent System is a sterile single-use device/drug combination product, comprised of a cobalt chromium (CoCr) alloy-based stent coated with a bioresorbable polymer mesh which is embedded with drug, mounted on a Rapid Exchange (RX) delivery system.
InCor
São Paulo, Brazil
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, Israel
Sourasky Medical Center
Tel Aviv, Israel
1In-stent Late Loss (LL)
In-stent Late Loss (LL) at 1 year (cohort B) assessed by quantitative coronary angiography (QCA) (Minimal Lumen Diameter (MLD) post-procedure - MLD follow-up)
Time frame: 1 year
Target Lesion Failure
Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year
Time frame: 1 year
Major adverse cardiac events
Major adverse cardiac events (MACE; the composite rate of cardiovascular death, any MI or ischemia-driven target lesion revascularization (TLR))
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
All-cause mortality
All-cause mortality.
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Cardiovascular death
Cardiovascular death.
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Myocardial infarction
Myocardial infarction.
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Target vessel related MI
Target vessel related MI.
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Target Lesion Failure
Target Lesion Failure (TLF)
Time frame: 6 months, 2, 3, 4, 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ischemia-driven TLR
Ischemia-driven Target Lesion Revascularization
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Ischemia-driven Target Vessel Revascularization
Ischemia-driven Target Vessel Revascularization.
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Stent thrombosis
Stent thrombosis (ARC-2 definite and probable)
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Acute Device Success
Acute Device Success (successful crossing and deployment with residual QCA DS \<30%).
Time frame: index procedure
Luminal gain
Luminal gain (MLD post-procedure - MLD pre-procedure).
Time frame: Cohort A: 30 days Cohort B: 12 months
In-stent MLD
In-stent Minimal Lumen Diameter
Time frame: Cohort A: 30 days Cohort B: 12 months
In-segment MLD
In-segment (+5mm from the stent edges) MLD
Time frame: Cohort A: 30 days Cohort B: 12 months
In-segment late loss
In-segment (+5mm from the stent edges) late loss
Time frame: Cohort A: 30 days Cohort B: 12 months
Proximal late loss
Proximal late loss (+5 mm from proximal stent edge)
Time frame: Cohort A: 30 days Cohort B: 12 months
Distal late loss
Distal late loss (+5 mm from distal stent edge)
Time frame: Cohort A: 30 days Cohort B: 12 months
In-stent and in-segment Binary Restenosis
In-stent and in-segment Binary Restenosis.
Time frame: Cohort A: 30 days Cohort B: 12 months
OCT-determined inner layer percent neointimal hyperplasia volume
CT-determined inner layer percent neointimal hyperplasia volume.
Time frame: Cohort A: 30 days Cohort B: 12 months
In-stent MLA
In-stent Minimum Lumen Area
Time frame: Cohort A: 30 days Cohort B: 12 months
In-segment minimum lumen area
In-segment minimum lumen area (MLA)
Time frame: Cohort A: 30 days Cohort B: 12 months
Minimal stent area
Minimal stent area (MSA)
Time frame: Cohort A: 30 days Cohort B: 12 months
Stent expansion
Stent expansion.
Time frame: Cohort A: 30 days Cohort B: 12 months
Edge dissection
Edge dissection.
Time frame: Cohort A: 30 days Cohort B: 12 months
NIH percentage at the MLA
NIH (Neointimal hyperplasia) percentage at the MLA
Time frame: Cohort A: 30 days Cohort B: 12 months
Percentage of Area stenosis at the MLA
Percentage of Area stenosis at the MLA.
Time frame: Cohort A: 30 days Cohort B: 12 months
Luminal gain
Luminal gain (MLA post-procedure - MLA pre-procedure)
Time frame: Cohort A: 30 days Cohort B: 12 months
In-stent late loss MLA
In-stent late loss MLA.
Time frame: Cohort A: 30 days Cohort B: 12 months
In-segment (+5 mm from the stent edges) late loss (MLA)
In-segment (+5 mm from the stent edges) late loss (MLA).
Time frame: Cohort A: 30 days Cohort B: 12 months
Proximal late loss (+5 mm from proximal stent edge) (MLA)
Proximal late loss (+5 mm from proximal stent edge) (MLA).
Time frame: Cohort A: 30 days Cohort B: 12 months
Distal late loss (+5 mm from distal stent edge) (MLA)
Distal late loss (+5 mm from distal stent edge) (MLA).
Time frame: Cohort A: 30 days Cohort B: 12 months
Intraluminal mass at least 0.2 mm beyond the luminal edge of a strut
Intraluminal mass at least 0.2 mm beyond the luminal edge of a strut (Intraluminal mass attached to the vessel is defined as an irregularly shaped structure in contact with the luminal contour, a free intraluminal mass is defined as an isolated structure in the lumen without contact to the vessel wall)
Time frame: Cohort A: 30 days Cohort B: 12 months
Malapposition
Malapposition (stent struts clearly separated from the vessel wall (lumen border/plaque surface) without tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm not associated with any side branch)
Time frame: Cohort A: 30 days Cohort B: 12 months
Percentage of Covered strut
Percentage of Covered strut (NIH thickness of \>0 μm)
Time frame: Cohort A: 30 days Cohort B: 12 months
Percentage of Healthy covered strut
Percentage of Healthy covered strut (NIH thickness≥40 μm)
Time frame: Cohort A: 30 days Cohort B: 12 months
Peri-strut low intensity area
Peri-strut low intensity area (peri-strut region of homogeneous lower intensity observed without signal attenuation)
Time frame: Cohort A: 30 days Cohort B: 12 months
Healing score
Healing score (defined as % intraluminal mass \[=intraluminal mass volume/stent volume\] ×4 + % malposed and uncovered struts ×3 + (% uncovered struts alone ×2 + % malposed struts alone ×1) 1. Intraluminal mass (+4). 2. Malposed and uncovered struts (+3). 3. Uncovered struts alone (+2). 4. Malposed struts alone (+1)
Time frame: Cohort A: 30 days Cohort B: 12 months