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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06071702
Other study ID # IoNIR-002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2024
Est. completion date August 2029

Study information

Verified date October 2023
Source Medinol Ltd.
Contact Brenda Koltun Reuven
Phone +972542666688
Email brendak@medinol.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, multi-center, single-arm, open-label, early feasibility study to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
IoNIR Ridaforolimus-Eluting Coronary Stent System
The IoNIR Ridaforolimus-Eluting Coronary Stent System is a sterile single-use device/drug combination product, comprised of a cobalt chromium (CoCr) alloybased stent coated with a bioresorbable polymer mesh which is embedded with drug, mounted on a Rapid Exchange (RX) delivery system.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medinol Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary In-stent Late Loss (LL) In-stent Late Loss (LL) at 13 months assessed by quantitative coronary angiography (QCA) (Minimal Lumen Diameter (MLD) post-procedure - MLD follow-up (US patients only)) 13 months
Primary Target Lesion Failure Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) 1 year
Secondary Major adverse cardiac events Major adverse cardiac events (MACE; the composite rate of cardiovascular death, any MI or ischemia-driven target lesion revascularization (TLR)). 30 days, 6 months, 1,2,3,4,5 years
Secondary All-cause mortality All-cause mortality 30 days, 6 months, 1,2,3,4,5 years
Secondary Cardiovascular death Cardiovascular death 30 days, 6 months, 1,2,3,4,5 years
Secondary Myocardial infarction Myocardial infarction 30 days, 6 months, 1,2,3,4,5 years
Secondary Target vessel related MI Target vessel related MI 30 days, 6 months, 1,2,3,4,5 years
Secondary Target Lesion Failure Target Lesion Failure 6 months, 2, 3, 4, 5 years
Secondary Ischemia-driven TLR Ischemia-driven TLR 30 days, 6 months, 1, 2, 3, 4, 5 years
Secondary Ischemia-driven Target Vessel Revascularization Ischemia-driven Target Vessel Revascularization 30 days, 6 months, 1, 2, 3, 4, 5 years
Secondary Stent thrombosis Stent thrombosis (ARC-2 definite and probable). 30 days, 6 months, 1, 2, 3, 4, 5 years
Secondary Acute Device Success Acute Device Success (successful crossing and deployment with residual QCA DS <30%) index procedure
Secondary Luminal gain Luminal gain (MLD post-procedure - MLD pre-procedure) 13 months - US patients only
Secondary In-stent MLD In-stent MLD 13 months - US patients only
Secondary In-segment MLD In-segment (+5mm from the stent edges) MLD 13 months - US patients only
Secondary In-segment late loss In-segment (+5mm from the stent edges) late loss 13 months - US patients only
Secondary Proximal late loss Proximal late loss (+5 mm from proximal stent edge) 13 months - US patients only
Secondary Distal late loss Distal late loss (+5 mm from proximal stent edge) 13 months - US patients only
Secondary In-stent and in-segment Binary Restenosis In-stent and in-segment Binary Restenosis 13 months - US patients only
Secondary OCT-determined inner layer percent neointimal hyperplasia volume OCT-determined inner layer percent neointimal hyperplasia volume 13 months - US patients only
Secondary In-stent MLA In-stent MLA 13 months - US patients only
Secondary In-segment minimum lumen area (MLA) In-segment minimum lumen area (MLA) 13 months - US patients only
Secondary Minimal stent area (MSA) Minimal stent area (MSA) 13 months - US patients only
Secondary Stent expansion Stent expansion 13 months - US patients only
Secondary Edge dissection Edge dissection 13 months - US patients only
Secondary % NIH at the MLA % NIH at the MLA 13 months - US patients only
Secondary % Area stenosis at the MLA % Area stenosis at the MLA 13 months - US patients only
Secondary Luminal gain (MLA post-procedure - MLA pre-procedure) Luminal gain (MLA post-procedure - MLA pre-procedure) 13 months - US patients only
Secondary In-stent late loss MLA In-stent late loss MLA 13 months - US patients only
Secondary In-segment (+5 mm from the stent edges) late loss (MLA). In-segment (+5 mm from the stent edges) late loss (MLA). 13 months - US patients only
Secondary Proximal late loss (+5 mm from proximal stent edge) (MLA) Proximal late loss (+5 mm from proximal stent edge) (MLA) 13 months - US patients only
Secondary Distal late loss (+5 mm from distal stent edge) (MLA) Distal late loss (+5 mm from distal stent edge) (MLA) 13 months - US patients only
Secondary 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) 13 months - US patients only
Secondary 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) 13 months - US patients only
Secondary % Covered strut % Covered strut (NIH thickness of >0 µm). 13 months - US patients only
Secondary % Healthy covered strut % Healthy covered strut (NIH thickness=40 µm). 13 months - US patients only
Secondary Peri-strut low intensity area Peri-strut low intensity area (peri-strut region of homogeneous lower intensity observed without signal attenuation). 13 months - US patients only
Secondary 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) at 13 months.
Intraluminal mass (+4).
Malposed and uncovered struts (+3).
Uncovered struts alone (+2).
Malposed struts alone (+1).
13 months - US patients only
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