Clinical trial NCT05364697: IonMAN Trial- First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
Official title: IonMAN Trial-First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Stenosis
Coronary Disease
Non-ST Elevated Myocardial Infarction
Cardiovascular Diseases
Lead sponsor: Medinol Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. 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).
3. Non-target vessel PCIs are allowed if performed \>30 days prior to index procedure.
4. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
5. 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.
6. One de novo target lesion ONLY may be treated (more than one lesion separated by less than 5 mm are considered one lesion).
7. 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:

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. Relative or absolute 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, 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. More than one lesion of greater than 50% stenosis in the target vessel.
34. Complex lesions including severely calcified lesions, lesions requiring scoring/cutting and/or rotational/orbital atherectomy and/or intra-vascular lithotripsy, 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.
35. 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.
36. Ostial lesions within 3 mm of LAD, LCx, RCA ostia, lesions in the LM

Primary outcomes:
measure: 1In-stent Late Loss (LL)
timeFrame: 1 year
measure: Target Lesion Failure
timeFrame: 1 year
Secondary outcomes:
measure: Major adverse cardiac events
timeFrame: 30 days, 6 months, 1, 2, 3, 4, 5 years
measure: All-cause mortality
timeFrame: 30 days, 6 months, 1, 2, 3, 4, 5 years
measure: Cardiovascular death
timeFrame: 30 days, 6 months, 1, 2, 3, 4, 5 years
measure: Myocardial infarction
timeFrame: 30 days, 6 months, 1, 2, 3, 4, 5 years
measure: Target vessel related MI
timeFrame: 30 days, 6 months, 1, 2, 3, 4, 5 years
measure: Target Lesion Failure
timeFrame: 6 months, 2, 3, 4, 5 years
measure: Ischemia-driven TLR
timeFrame: 30 days, 6 months, 1, 2, 3, 4, 5 years
measure: Ischemia-driven Target Vessel Revascularization
timeFrame: 30 days, 6 months, 1, 2, 3, 4, 5 years
measure: Stent thrombosis
timeFrame: 30 days, 6 months, 1, 2, 3, 4, 5 years
measure: Acute Device Success
timeFrame: index procedure
measure: Luminal gain
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: In-stent MLD
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: In-segment MLD
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: In-segment late loss
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Proximal late loss
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Distal late loss
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: In-stent and in-segment Binary Restenosis
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: OCT-determined inner layer percent neointimal hyperplasia volume
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: In-stent MLA
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: In-segment minimum lumen area
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Minimal stent area
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Stent expansion
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Edge dissection
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: NIH percentage at the MLA
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Percentage of Area stenosis at the MLA
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Luminal gain
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: In-stent late loss MLA
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: In-segment (+5 mm from the stent edges) late loss (MLA)
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Proximal late loss (+5 mm from proximal stent edge) (MLA)
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Distal late loss (+5 mm from distal stent edge) (MLA)
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Intraluminal mass at least 0.2 mm beyond the luminal edge of a strut
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Malapposition
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Percentage of Covered strut
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Percentage of Healthy covered strut
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Peri-strut low intensity area
timeFrame: Cohort A: 30 days Cohort B: 12 months
measure: Healing score
timeFrame: Cohort A: 30 days Cohort B: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: InCor
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
References: