IonMAN Trial- First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System

NCT ID: NCT05364697

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2029-12-31

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.

Conditions

Coronary Stenosis; Coronary Disease; Non-ST Elevated Myocardial Infarction; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IoNIR Ridaforolimus-Eluting Coronary Stent

IoNIR Ridaforolimus-Eluting Coronary Stent System

Group Type: EXPERIMENTAL

IoNIR Ridaforolimus-Eluting Coronary Stent System

Intervention Type: 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.

Interventions

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) alloy-based stent coated with a bioresorbable polymer mesh which is embedded with drug, mounted on a Rapid Exchange (RX) delivery system.

Intervention Type: DEVICE

Other Intervention Names

IoNIR

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medinol Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

InCor

São Paulo, , Brazil

Meir Medical Center

Kfar Saba, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

Countries

Brazil; Israel

Other Identifiers

IoNIR-001

Identifier Type: -

Identifier Source: org_study_id