Coronary StenosisNCT06071702
IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
A study testing IoNIR Ridaforolimus-Eluting Coronary Stent System in people with Coronary Stenosis and Coronary Artery Disease, run by Medinol Ltd. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis, Coronary Artery Disease
- What is being tested?
- IoNIR Ridaforolimus-Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to 7 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St Francis Hospital Heart Center
Roslyn, New York, 11576
About this study
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
- Conditions
- Coronary Stenosis, Coronary Artery Disease
- Being tested
- IoNIR Ridaforolimus-Eluting Coronary Stent System
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IoNIR Ridaforolimus-Eluting Coronary Stent SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| IoNIR Ridaforolimus-Eluting Coronary Stent | Experimental | IoNIR Ridaforolimus-Eluting Coronary Stent System Receives: Device: IoNIR Ridaforolimus-Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 13 months
Target Lesion Failure
Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization)
Measured: 1 year
Secondary outcomes (36)
Major adverse cardiac events
Major adverse cardiac events (MACE; the composite rate of cardiovascular death, any MI or ischemia-driven target lesion revascularization (TLR)).
Measured: 30 days, 6 months, 1,2,3,4,5 years
All-cause mortality
All-cause mortality
Measured: 30 days, 6 months, 1,2,3,4,5 years
Cardiovascular death
Cardiovascular death
Measured: 30 days, 6 months, 1,2,3,4,5 years
Myocardial infarction
Myocardial infarction
Measured: 30 days, 6 months, 1,2,3,4,5 years
Target vessel related MI
Target vessel related MI
Measured: 30 days, 6 months, 1,2,3,4,5 years
Target Lesion Failure
Target Lesion Failure
Measured: 6 months, 2, 3, 4, 5 years
Ischemia-driven TLR
Ischemia-driven TLR
Measured: 30 days, 6 months, 1, 2, 3, 4, 5 years
Ischemia-driven Target Vessel Revascularization
Ischemia-driven Target Vessel Revascularization
Measured: 30 days, 6 months, 1, 2, 3, 4, 5 years
Stent thrombosis
Stent thrombosis (ARC-2 definite and probable).
Measured: 30 days, 6 months, 1, 2, 3, 4, 5 years
Acute Device Success
Acute Device Success (successful crossing and deployment with residual QCA DS <30%)
Measured: index procedure
Luminal gain
Luminal gain (MLD post-procedure - MLD pre-procedure)
Measured: 13 months - US patients only
In-stent MLD
In-stent MLD
Measured: 13 months - US patients only
In-segment MLD
In-segment (+5mm from the stent edges) MLD
Measured: 13 months - US patients only
In-segment late loss
In-segment (+5mm from the stent edges) late loss
Measured: 13 months - US patients only
Proximal late loss
Proximal late loss (+5 mm from proximal stent edge)
Measured: 13 months - US patients only
Distal late loss
Distal late loss (+5 mm from proximal stent edge)
Measured: 13 months - US patients only
In-stent and in-segment Binary Restenosis
In-stent and in-segment Binary Restenosis
Measured: 13 months - US patients only
OCT-determined inner layer percent neointimal hyperplasia volume
OCT-determined inner layer percent neointimal hyperplasia volume
Measured: 13 months - US patients only
In-stent MLA
In-stent MLA
Measured: 13 months - US patients only
In-segment minimum lumen area (MLA)
In-segment minimum lumen area (MLA)
Measured: 13 months - US patients only
Minimal stent area (MSA)
Minimal stent area (MSA)
Measured: 13 months - US patients only
Stent expansion
Stent expansion
Measured: 13 months - US patients only
Edge dissection
Edge dissection
Measured: 13 months - US patients only
% NIH at the MLA
% NIH at the MLA
Measured: 13 months - US patients only
% Area stenosis at the MLA
% Area stenosis at the MLA
Measured: 13 months - US patients only
Luminal gain (MLA post-procedure - MLA pre-procedure)
Luminal gain (MLA post-procedure - MLA pre-procedure)
Measured: 13 months - US patients only
In-stent late loss MLA
In-stent late loss MLA
Measured: 13 months - US patients only
In-segment (+5 mm from the stent edges) late loss (MLA).
In-segment (+5 mm from the stent edges) late loss (MLA).
Measured: 13 months - US patients only
Proximal late loss (+5 mm from proximal stent edge) (MLA)
Proximal late loss (+5 mm from proximal stent edge) (MLA)
Measured: 13 months - US patients only
Distal late loss (+5 mm from distal stent edge) (MLA)
Distal late loss (+5 mm from distal stent edge) (MLA)
Measured: 13 months - US patients only
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)
Measured: 13 months - US patients only
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)
Measured: 13 months - US patients only
% Covered strut
% Covered strut (NIH thickness of >0 μm).
Measured: 13 months - US patients only
% Healthy covered strut
% Healthy covered strut (NIH thickness≥40 μm).
Measured: 13 months - US patients only
Peri-strut low intensity area
Peri-strut low intensity area (peri-strut region of homogeneous lower intensity observed without signal attenuation).
Measured: 13 months - US patients only
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).
Measured: 13 months - US patients only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start7 Aug 2025
- Primary completion7 Aug 2025
- Study completion7 Dec 2026 (estimated)
Why it stopped: Study was not initiated in any site. Sponsor decided not to start the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medinol Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071702
- Sponsor's protocol ID
- IoNIR-002
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
- ClinicalTrials.gov ID
- NCT06071702
- Acronym / sponsor ID
- IoNIR-002
- Conditions
- Coronary Stenosis, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study was not initiated in any site. Sponsor decided not to start the study
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medinol Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IoNIR Ridaforolimus-Eluting Coronary Stent | Experimental | Device: IoNIR Ridaforolimus-Eluting Coronary Stent SystemIoNIR Ridaforolimus-Eluting Coronary Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IoNIR Ridaforolimus-Eluting Coronary Stent SystemThe 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. | Device | IoNIR Ridaforolimus-Eluting Coronary Stent |
Primary outcome
In-stent Late Loss (LL)
Time frame: 13 months
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
Time frame: 1 year
Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization)
36 secondary outcomes
Major adverse cardiac events
Time frame: 30 days, 6 months, 1,2,3,4,5 years
All-cause mortality
Time frame: 30 days, 6 months, 1,2,3,4,5 years
Cardiovascular death
Time frame: 30 days, 6 months, 1,2,3,4,5 years
Myocardial infarction
Time frame: 30 days, 6 months, 1,2,3,4,5 years
Target vessel related MI
Time frame: 30 days, 6 months, 1,2,3,4,5 years
Target Lesion Failure
Time frame: 6 months, 2, 3, 4, 5 years
Ischemia-driven TLR
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Ischemia-driven Target Vessel Revascularization
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Stent thrombosis
Time frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
Acute Device Success
Time frame: index procedure
Luminal gain
Time frame: 13 months - US patients only
In-stent MLD
Time frame: 13 months - US patients only
In-segment MLD
Time frame: 13 months - US patients only
In-segment late loss
Time frame: 13 months - US patients only
Proximal late loss
Time frame: 13 months - US patients only
Distal late loss
Time frame: 13 months - US patients only
In-stent and in-segment Binary Restenosis
Time frame: 13 months - US patients only
OCT-determined inner layer percent neointimal hyperplasia volume
Time frame: 13 months - US patients only
In-stent MLA
Time frame: 13 months - US patients only
In-segment minimum lumen area (MLA)
Time frame: 13 months - US patients only
Minimal stent area (MSA)
Time frame: 13 months - US patients only
Stent expansion
Time frame: 13 months - US patients only
Edge dissection
Time frame: 13 months - US patients only
% NIH at the MLA
Time frame: 13 months - US patients only
% Area stenosis at the MLA
Time frame: 13 months - US patients only
Luminal gain (MLA post-procedure - MLA pre-procedure)
Time frame: 13 months - US patients only
In-stent late loss MLA
Time frame: 13 months - US patients only
In-segment (+5 mm from the stent edges) late loss (MLA).
Time frame: 13 months - US patients only
Proximal late loss (+5 mm from proximal stent edge) (MLA)
Time frame: 13 months - US patients only
Distal late loss (+5 mm from distal stent edge) (MLA)
Time frame: 13 months - US patients only
Intraluminal mass at least 0.2 mm beyond the luminal edge of a strut
Time frame: 13 months - US patients only
Malapposition
Time frame: 13 months - US patients only
% Covered strut
Time frame: 13 months - US patients only
% Healthy covered strut
Time frame: 13 months - US patients only
Peri-strut low intensity area
Time frame: 13 months - US patients only
Healing score
Time frame: 13 months - US patients only
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IoNIR Ridaforolimus-Eluting Coronary Stent System in people with Coronary Stenosis and Coronary Artery Disease, run by Medinol Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent Late Loss (LL) (time frame: 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.