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IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System

Primary Purpose

Coronary Stenosis, Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IoNIR Ridaforolimus-Eluting Coronary Stent System
Sponsored by
Medinol Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. A maximum of two vessels and up to two lesions may be treated (two lesions separated by up to 10mm that can be covered by a single stent are considered as one lesion). Lesions requiring scoring/cutting and/or rotational/orbital atherectomy and/or intra-vascular lithotripsy are allowed. Overlapping stents are allowed. 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 40 mm, and appropriate size IoNIR stents are available. Exclusion Criteria: 1. ST Segment Elevation MI within past 30 days. 2. NSTEMI with biomarkers that have not peaked. 3. Significant valvular disease or planned valvular intervention. 4. PCI within the 30 days preceding the baseline procedure. 5. PCI in the target vessel within 12 months of the baseline procedure. 6. Planned staged procedures (coronary or valvular), where the study stent is implanted in the first stage. 7. Brachytherapy in conjunction with the baseline procedure. 8. Known history of stent thrombosis. 9. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP. 10. Subject is intubated. 11. Known LVEF <30%. 12. Contraindication to DAPT for 6 months in non-ACS patients and 12 months in ACS patients (including planned surgeries that cannot be delayed). 13. Subject has an indication such as atrial fibrillation for oral anticoagulation/prolonged heparinization (i.e., use of coumadin/DOAC (NOAC) or prolonged enoxaparin/heparin therapy is not allowed). 14. eGFR <60 mL/min. 15. Hemoglobin <10 g/dL. 16. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3. 17. White blood cell (WBC) count <3,000 cells/mm3. 18. Clinically significant liver disease. 19. Active peptic ulcer or active bleeding from any site. 20. Bleeding from any site within the previous 8 weeks requiring active medical or surgical attention. 21. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath. 22. History of bleeding diathesis or coagulopathy and patients that refuse blood transfusions. 23. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA. 24. Known allergy to the study stent components (cobalt, nickel, chromium, molybdenum, platinum, PDLG, PLC, or limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds). 25. Known allergy to protocol-required concomitant medications such as aspirin, or P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor), heparin and bivalirudin, or iodinated contrast allergy that cannot be adequately pre-medicated. 26. Any co-morbid condition that may cause non-compliance with the protocol (e.g., dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g., cancer, severe heart failure, severe lung disease). 27. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint. 28. Women who are pregnant or breastfeeding. 29. Women who intend to become pregnant within 12 months after the baseline procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the baseline procedure). 30. Patient has received an organ transplant or is on a waiting list for an organ transplant. 31. Patient is receiving or scheduled to receive chemotherapy within 30 days before or any time after the baseline procedure. 32. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are allowed. 33. Complex lesions including severely calcified lesions, presence of visible thrombus, chronic total occlusions, bifurcation lesions (side branch diameter ≥2.0 mm), tortuous lesions, restenotic lesions, left main lesions, ectasia, aneurysm and any bypass graft lesions. 34. Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 12 months after the baseline procedure. 35. Ostial lesions within 3 mm of origin of LAD, LCx, lesions in the LM.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    IoNIR Ridaforolimus-Eluting Coronary Stent

    Arm Description

    IoNIR Ridaforolimus-Eluting Coronary Stent System

    Outcomes

    Primary Outcome Measures

    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))
    Target Lesion Failure
    Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization)

    Secondary Outcome Measures

    Major adverse cardiac events
    Major adverse cardiac events (MACE; the composite rate of cardiovascular death, any MI or ischemia-driven target lesion revascularization (TLR)).
    All-cause mortality
    All-cause mortality
    Cardiovascular death
    Cardiovascular death
    Myocardial infarction
    Myocardial infarction
    Target vessel related MI
    Target vessel related MI
    Target Lesion Failure
    Target Lesion Failure
    Ischemia-driven TLR
    Ischemia-driven TLR
    Ischemia-driven Target Vessel Revascularization
    Ischemia-driven Target Vessel Revascularization
    Stent thrombosis
    Stent thrombosis (ARC-2 definite and probable).
    Acute Device Success
    Acute Device Success (successful crossing and deployment with residual QCA DS <30%)
    Luminal gain
    Luminal gain (MLD post-procedure - MLD pre-procedure)
    In-stent MLD
    In-stent MLD
    In-segment MLD
    In-segment (+5mm from the stent edges) MLD
    In-segment late loss
    In-segment (+5mm from the stent edges) late loss
    Proximal late loss
    Proximal late loss (+5 mm from proximal stent edge)
    Distal late loss
    Distal late loss (+5 mm from proximal stent edge)
    In-stent and in-segment Binary Restenosis
    In-stent and in-segment Binary Restenosis
    OCT-determined inner layer percent neointimal hyperplasia volume
    OCT-determined inner layer percent neointimal hyperplasia volume
    In-stent MLA
    In-stent MLA
    In-segment minimum lumen area (MLA)
    In-segment minimum lumen area (MLA)
    Minimal stent area (MSA)
    Minimal stent area (MSA)
    Stent expansion
    Stent expansion
    Edge dissection
    Edge dissection
    % NIH at the MLA
    % NIH at the MLA
    % Area stenosis at the MLA
    % Area stenosis at the MLA
    Luminal gain (MLA post-procedure - MLA pre-procedure)
    Luminal gain (MLA post-procedure - MLA pre-procedure)
    In-stent late loss MLA
    In-stent late loss MLA
    In-segment (+5 mm from the stent edges) late loss (MLA).
    In-segment (+5 mm from the stent edges) late loss (MLA).
    Proximal late loss (+5 mm from proximal stent edge) (MLA)
    Proximal late loss (+5 mm from proximal stent edge) (MLA)
    Distal late loss (+5 mm from distal stent edge) (MLA)
    Distal late loss (+5 mm from distal stent edge) (MLA)
    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)
    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)
    % Covered strut
    % Covered strut (NIH thickness of >0 μm).
    % Healthy covered strut
    % Healthy covered strut (NIH thickness≥40 μm).
    Peri-strut low intensity area
    Peri-strut low intensity area (peri-strut region of homogeneous lower intensity observed without signal attenuation).
    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).

    Full Information

    First Posted
    October 1, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Medinol Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06071702
    Brief Title
    IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
    Official Title
    IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2024 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    August 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medinol Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Stenosis, Coronary Artery Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IoNIR Ridaforolimus-Eluting Coronary Stent
    Arm Type
    Experimental
    Arm Description
    IoNIR Ridaforolimus-Eluting Coronary Stent System
    Intervention Type
    Device
    Intervention Name(s)
    IoNIR Ridaforolimus-Eluting Coronary Stent System
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    In-stent Late Loss (LL)
    Description
    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))
    Time Frame
    13 months
    Title
    Target Lesion Failure
    Description
    Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Major adverse cardiac events
    Description
    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
    Title
    All-cause mortality
    Description
    All-cause mortality
    Time Frame
    30 days, 6 months, 1,2,3,4,5 years
    Title
    Cardiovascular death
    Description
    Cardiovascular death
    Time Frame
    30 days, 6 months, 1,2,3,4,5 years
    Title
    Myocardial infarction
    Description
    Myocardial infarction
    Time Frame
    30 days, 6 months, 1,2,3,4,5 years
    Title
    Target vessel related MI
    Description
    Target vessel related MI
    Time Frame
    30 days, 6 months, 1,2,3,4,5 years
    Title
    Target Lesion Failure
    Description
    Target Lesion Failure
    Time Frame
    6 months, 2, 3, 4, 5 years
    Title
    Ischemia-driven TLR
    Description
    Ischemia-driven TLR
    Time Frame
    30 days, 6 months, 1, 2, 3, 4, 5 years
    Title
    Ischemia-driven Target Vessel Revascularization
    Description
    Ischemia-driven Target Vessel Revascularization
    Time Frame
    30 days, 6 months, 1, 2, 3, 4, 5 years
    Title
    Stent thrombosis
    Description
    Stent thrombosis (ARC-2 definite and probable).
    Time Frame
    30 days, 6 months, 1, 2, 3, 4, 5 years
    Title
    Acute Device Success
    Description
    Acute Device Success (successful crossing and deployment with residual QCA DS <30%)
    Time Frame
    index procedure
    Title
    Luminal gain
    Description
    Luminal gain (MLD post-procedure - MLD pre-procedure)
    Time Frame
    13 months - US patients only
    Title
    In-stent MLD
    Description
    In-stent MLD
    Time Frame
    13 months - US patients only
    Title
    In-segment MLD
    Description
    In-segment (+5mm from the stent edges) MLD
    Time Frame
    13 months - US patients only
    Title
    In-segment late loss
    Description
    In-segment (+5mm from the stent edges) late loss
    Time Frame
    13 months - US patients only
    Title
    Proximal late loss
    Description
    Proximal late loss (+5 mm from proximal stent edge)
    Time Frame
    13 months - US patients only
    Title
    Distal late loss
    Description
    Distal late loss (+5 mm from proximal stent edge)
    Time Frame
    13 months - US patients only
    Title
    In-stent and in-segment Binary Restenosis
    Description
    In-stent and in-segment Binary Restenosis
    Time Frame
    13 months - US patients only
    Title
    OCT-determined inner layer percent neointimal hyperplasia volume
    Description
    OCT-determined inner layer percent neointimal hyperplasia volume
    Time Frame
    13 months - US patients only
    Title
    In-stent MLA
    Description
    In-stent MLA
    Time Frame
    13 months - US patients only
    Title
    In-segment minimum lumen area (MLA)
    Description
    In-segment minimum lumen area (MLA)
    Time Frame
    13 months - US patients only
    Title
    Minimal stent area (MSA)
    Description
    Minimal stent area (MSA)
    Time Frame
    13 months - US patients only
    Title
    Stent expansion
    Description
    Stent expansion
    Time Frame
    13 months - US patients only
    Title
    Edge dissection
    Description
    Edge dissection
    Time Frame
    13 months - US patients only
    Title
    % NIH at the MLA
    Description
    % NIH at the MLA
    Time Frame
    13 months - US patients only
    Title
    % Area stenosis at the MLA
    Description
    % Area stenosis at the MLA
    Time Frame
    13 months - US patients only
    Title
    Luminal gain (MLA post-procedure - MLA pre-procedure)
    Description
    Luminal gain (MLA post-procedure - MLA pre-procedure)
    Time Frame
    13 months - US patients only
    Title
    In-stent late loss MLA
    Description
    In-stent late loss MLA
    Time Frame
    13 months - US patients only
    Title
    In-segment (+5 mm from the stent edges) late loss (MLA).
    Description
    In-segment (+5 mm from the stent edges) late loss (MLA).
    Time Frame
    13 months - US patients only
    Title
    Proximal late loss (+5 mm from proximal stent edge) (MLA)
    Description
    Proximal late loss (+5 mm from proximal stent edge) (MLA)
    Time Frame
    13 months - US patients only
    Title
    Distal late loss (+5 mm from distal stent edge) (MLA)
    Description
    Distal late loss (+5 mm from distal stent edge) (MLA)
    Time Frame
    13 months - US patients only
    Title
    Intraluminal mass at least 0.2 mm beyond the luminal edge of a strut
    Description
    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
    13 months - US patients only
    Title
    Malapposition
    Description
    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
    13 months - US patients only
    Title
    % Covered strut
    Description
    % Covered strut (NIH thickness of >0 μm).
    Time Frame
    13 months - US patients only
    Title
    % Healthy covered strut
    Description
    % Healthy covered strut (NIH thickness≥40 μm).
    Time Frame
    13 months - US patients only
    Title
    Peri-strut low intensity area
    Description
    Peri-strut low intensity area (peri-strut region of homogeneous lower intensity observed without signal attenuation).
    Time Frame
    13 months - US patients only
    Title
    Healing score
    Description
    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).
    Time Frame
    13 months - US patients only

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. A maximum of two vessels and up to two lesions may be treated (two lesions separated by up to 10mm that can be covered by a single stent are considered as one lesion). Lesions requiring scoring/cutting and/or rotational/orbital atherectomy and/or intra-vascular lithotripsy are allowed. Overlapping stents are allowed. 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 40 mm, and appropriate size IoNIR stents are available. Exclusion Criteria: 1. ST Segment Elevation MI within past 30 days. 2. NSTEMI with biomarkers that have not peaked. 3. Significant valvular disease or planned valvular intervention. 4. PCI within the 30 days preceding the baseline procedure. 5. PCI in the target vessel within 12 months of the baseline procedure. 6. Planned staged procedures (coronary or valvular), where the study stent is implanted in the first stage. 7. Brachytherapy in conjunction with the baseline procedure. 8. Known history of stent thrombosis. 9. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP. 10. Subject is intubated. 11. Known LVEF <30%. 12. Contraindication to DAPT for 6 months in non-ACS patients and 12 months in ACS patients (including planned surgeries that cannot be delayed). 13. Subject has an indication such as atrial fibrillation for oral anticoagulation/prolonged heparinization (i.e., use of coumadin/DOAC (NOAC) or prolonged enoxaparin/heparin therapy is not allowed). 14. eGFR <60 mL/min. 15. Hemoglobin <10 g/dL. 16. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3. 17. White blood cell (WBC) count <3,000 cells/mm3. 18. Clinically significant liver disease. 19. Active peptic ulcer or active bleeding from any site. 20. Bleeding from any site within the previous 8 weeks requiring active medical or surgical attention. 21. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath. 22. History of bleeding diathesis or coagulopathy and patients that refuse blood transfusions. 23. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA. 24. Known allergy to the study stent components (cobalt, nickel, chromium, molybdenum, platinum, PDLG, PLC, or limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds). 25. Known allergy to protocol-required concomitant medications such as aspirin, or P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor), heparin and bivalirudin, or iodinated contrast allergy that cannot be adequately pre-medicated. 26. Any co-morbid condition that may cause non-compliance with the protocol (e.g., dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g., cancer, severe heart failure, severe lung disease). 27. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint. 28. Women who are pregnant or breastfeeding. 29. Women who intend to become pregnant within 12 months after the baseline procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the baseline procedure). 30. Patient has received an organ transplant or is on a waiting list for an organ transplant. 31. Patient is receiving or scheduled to receive chemotherapy within 30 days before or any time after the baseline procedure. 32. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are allowed. 33. Complex lesions including severely calcified lesions, presence of visible thrombus, chronic total occlusions, bifurcation lesions (side branch diameter ≥2.0 mm), tortuous lesions, restenotic lesions, left main lesions, ectasia, aneurysm and any bypass graft lesions. 34. Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 12 months after the baseline procedure. 35. Ostial lesions within 3 mm of origin of LAD, LCx, lesions in the LM.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brenda Koltun Reuven
    Phone
    +972542666688
    Email
    brendak@medinol.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System

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