Clinical trial NCT06071702: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Stenosis
Coronary Artery Disease
Lead sponsor: Medinol Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 30
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, early feasibility study 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. 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).
7. Lesions requiring scoring/cutting and/or rotational/orbital atherectomy and/or intra-vascular lithotripsy are allowed.
8. Overlapping stents are allowed.
9. 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.

Primary outcomes:
measure: In-stent Late Loss (LL)
timeFrame: 13 months
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: 13 months - US patients only
measure: In-stent MLD
timeFrame: 13 months - US patients only
measure: In-segment MLD
timeFrame: 13 months - US patients only
measure: In-segment late loss
timeFrame: 13 months - US patients only
measure: Proximal late loss
timeFrame: 13 months - US patients only
measure: Distal late loss
timeFrame: 13 months - US patients only
measure: In-stent and in-segment Binary Restenosis
timeFrame: 13 months - US patients only
measure: OCT-determined inner layer percent neointimal hyperplasia volume
timeFrame: 13 months - US patients only
measure: In-stent MLA
timeFrame: 13 months - US patients only
measure: In-segment minimum lumen area (MLA)
timeFrame: 13 months - US patients only
measure: Minimal stent area (MSA)
timeFrame: 13 months - US patients only
measure: Stent expansion
timeFrame: 13 months - US patients only
measure: Edge dissection
timeFrame: 13 months - US patients only
measure: % NIH at the MLA
timeFrame: 13 months - US patients only
measure: % Area stenosis at the MLA
timeFrame: 13 months - US patients only
measure: Luminal gain (MLA post-procedure - MLA pre-procedure)
timeFrame: 13 months - US patients only
measure: In-stent late loss MLA
timeFrame: 13 months - US patients only
measure: In-segment (+5 mm from the stent edges) late loss (MLA).
timeFrame: 13 months - US patients only
measure: Proximal late loss (+5 mm from proximal stent edge) (MLA)
timeFrame: 13 months - US patients only
measure: Distal late loss (+5 mm from distal stent edge) (MLA)
timeFrame: 13 months - US patients only
measure: Intraluminal mass at least 0.2 mm beyond the luminal edge of a strut
timeFrame: 13 months - US patients only
measure: Malapposition
timeFrame: 13 months - US patients only
measure: % Covered strut
timeFrame: 13 months - US patients only
measure: % Healthy covered strut
timeFrame: 13 months - US patients only
measure: Peri-strut low intensity area
timeFrame: 13 months - US patients only
measure: Healing score
timeFrame: 13 months - US patients only
Other outcomes:
Locations:
Study officials:
References: