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IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System | Clinical Trials | Clareo Health

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

NCT06071702•Medinol Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

Locations (1)

St Francis Hospital Heart Center

Roslyn, New York, United States

Key Dates

Start Date

August 7, 2025

Primary Completion Date

August 7, 2025

Completion Date

August 10, 2026

Last Updated

September 22, 2025

Enrollment

ESTIMATED participants

Conditions

Coronary StenosisCoronary Artery Disease

Interventions

IoNIR Ridaforolimus-Eluting Coronary Stent System

DEVICE

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Coronary Artery Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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