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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IoNIR Ridaforolimus-Eluting Coronary Stent | Experimental | IoNIR Ridaforolimus-Eluting Coronary Stent System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IoNIR Ridaforolimus-Eluting Coronary Stent System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| All-cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InCor | São Paulo | Brazil | ||||
| Meir Medical Center |
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All-cause mortality.
| 30 days, 6 months, 1, 2, 3, 4, 5 years |
| Cardiovascular death | Cardiovascular death. | 30 days, 6 months, 1, 2, 3, 4, 5 years |
| Myocardial infarction | Myocardial infarction. | 30 days, 6 months, 1, 2, 3, 4, 5 years |
| Target vessel related MI | Target vessel related MI. | 30 days, 6 months, 1, 2, 3, 4, 5 years |
| Target Lesion Failure | Target Lesion Failure (TLF) | 6 months, 2, 3, 4, 5 years |
| Ischemia-driven TLR | Ischemia-driven Target Lesion Revascularization | 30 days, 6 months, 1, 2, 3, 4, 5 years |
| Ischemia-driven Target Vessel Revascularization | Ischemia-driven Target Vessel Revascularization. | 30 days, 6 months, 1, 2, 3, 4, 5 years |
| Stent thrombosis | Stent thrombosis (ARC-2 definite and probable) | 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%). | index procedure |
| Luminal gain | Luminal gain (MLD post-procedure - MLD pre-procedure). | Cohort A: 30 days Cohort B: 12 months |
| In-stent MLD | In-stent Minimal Lumen Diameter | Cohort A: 30 days Cohort B: 12 months |
| In-segment MLD | In-segment (+5mm from the stent edges) MLD | Cohort A: 30 days Cohort B: 12 months |
| In-segment late loss | In-segment (+5mm from the stent edges) late loss | Cohort A: 30 days Cohort B: 12 months |
| Proximal late loss | Proximal late loss (+5 mm from proximal stent edge) | Cohort A: 30 days Cohort B: 12 months |
| Distal late loss | Distal late loss (+5 mm from distal stent edge) | Cohort A: 30 days Cohort B: 12 months |
| In-stent and in-segment Binary Restenosis | In-stent and in-segment Binary Restenosis. | Cohort A: 30 days Cohort B: 12 months |
| OCT-determined inner layer percent neointimal hyperplasia volume | CT-determined inner layer percent neointimal hyperplasia volume. | Cohort A: 30 days Cohort B: 12 months |
| In-stent MLA | In-stent Minimum Lumen Area | Cohort A: 30 days Cohort B: 12 months |
| In-segment minimum lumen area | In-segment minimum lumen area (MLA) | Cohort A: 30 days Cohort B: 12 months |
| Minimal stent area | Minimal stent area (MSA) | Cohort A: 30 days Cohort B: 12 months |
| Stent expansion | Stent expansion. | Cohort A: 30 days Cohort B: 12 months |
| Edge dissection | Edge dissection. | Cohort A: 30 days Cohort B: 12 months |
| NIH percentage at the MLA | NIH (Neointimal hyperplasia) percentage at the MLA | Cohort A: 30 days Cohort B: 12 months |
| Percentage of Area stenosis at the MLA | Percentage of Area stenosis at the MLA. | Cohort A: 30 days Cohort B: 12 months |
| Luminal gain | Luminal gain (MLA post-procedure - MLA pre-procedure) | Cohort A: 30 days Cohort B: 12 months |
| In-stent late loss MLA | In-stent late loss MLA. | 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). | 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). | 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). | 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) | 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) | Cohort A: 30 days Cohort B: 12 months |
| Percentage of Covered strut | Percentage of Covered strut (NIH thickness of >0 μm) | Cohort A: 30 days Cohort B: 12 months |
| Percentage of Healthy covered strut | Percentage of Healthy covered strut (NIH thickness≥40 μm) | 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) | 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)
| Cohort A: 30 days Cohort B: 12 months |
| Kfar Saba |
| Israel |
| Rabin Medical Center | Petah Tikva | Israel |
| Sourasky Medical Center | Tel Aviv | Israel |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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