Coronary StenosisIonMANNCT05364697
IonMAN Trial- First in Human 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 Disease, run by Medinol Ltd. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis, Coronary Disease, Non-ST Elevated Myocardial Infarction
- 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
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Aug 2022to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
- One de novo target lesion ONLY may be treated (more than one lesion separated by less than 5 mm are considered one lesion).
- 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
Who cannot join
- ST Segment Elevation MI within past 30 days.
- NSTEMI with biomarkers that have not peaked.
- Significant valvular disease or planned valvular intervention.
- PCI within the 30 days preceding the baseline procedure.
- PCI in the target vessel within 12 months of the baseline procedure.
- Planned staged procedures (coronary or valvular), where the study stent is implanted in the first stage.
Show all 36Show fewer
- Brachytherapy in conjunction with the baseline procedure.
- Known history of stent thrombosis.
- 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.
- Subject is intubated.
- Known LVEF <30%.
- 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).
- 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).
- eGFR <60 mL/min.
- Hemoglobin <10 g/dL.
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- White blood cell (WBC) count <3,000 cells/mm3.
- Clinically significant liver disease.
- Active peptic ulcer or active bleeding from any site
- Bleeding from any site within the previous 8 weeks requiring active medical or surgical attention.
- If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath.
- History of bleeding diathesis or coagulopathy and patients that refuse blood transfusions.
- Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.
- 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).
- 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.
- 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).
- Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint.
- Women who are pregnant or breastfeeding.
- 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).
- Patient has received an organ transplant or is on a waiting list for an organ transplant.
- Patient is receiving or scheduled to receive chemotherapy within 30 days before or any time after the baseline procedure.
- Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are allowed
- More than one lesion of greater than 50% stenosis in the target vessel.
- 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.
- 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.
- Ostial lesions within 3 mm of LAD, LCx, RCA ostia, lesions in the LM
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Israel3 sites
Meir Medical Center
Kfar Saba
Rabin Medical Center
Petah Tikva
Sourasky Medical Center
Tel Aviv
About this study
Official title: IonMAN Trial-First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
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
- Being tested
- IoNIR Ridaforolimus-Eluting Coronary Stent System
- Medical subject headings
- Coronary Stenosis, Coronary Disease, Non-ST Elevated Myocardial Infarction, Cardiovascular Diseases
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
Also called IoNIR
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.
| 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.
1In-stent Late Loss (LL)
In-stent Late Loss (LL) at 1 year (cohort B) assessed by quantitative coronary angiography (QCA) (Minimal Lumen Diameter (MLD) post-procedure - MLD follow-up)
Measured: 1 year
Target Lesion Failure
Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year
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 (TLF)
Measured: 6 months, 2, 3, 4, 5 years
Ischemia-driven TLR
Ischemia-driven Target Lesion Revascularization
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: Cohort A: 30 days Cohort B: 12 months
In-stent MLD
In-stent Minimal Lumen Diameter
Measured: Cohort A: 30 days Cohort B: 12 months
In-segment MLD
In-segment (+5mm from the stent edges) MLD
Measured: Cohort A: 30 days Cohort B: 12 months
In-segment late loss
In-segment (+5mm from the stent edges) late loss
Measured: Cohort A: 30 days Cohort B: 12 months
Proximal late loss
Proximal late loss (+5 mm from proximal stent edge)
Measured: Cohort A: 30 days Cohort B: 12 months
Distal late loss
Distal late loss (+5 mm from distal stent edge)
Measured: Cohort A: 30 days Cohort B: 12 months
In-stent and in-segment Binary Restenosis
In-stent and in-segment Binary Restenosis.
Measured: Cohort A: 30 days Cohort B: 12 months
OCT-determined inner layer percent neointimal hyperplasia volume
CT-determined inner layer percent neointimal hyperplasia volume.
Measured: Cohort A: 30 days Cohort B: 12 months
In-stent MLA
In-stent Minimum Lumen Area
Measured: Cohort A: 30 days Cohort B: 12 months
In-segment minimum lumen area
In-segment minimum lumen area (MLA)
Measured: Cohort A: 30 days Cohort B: 12 months
Minimal stent area
Minimal stent area (MSA)
Measured: Cohort A: 30 days Cohort B: 12 months
Stent expansion
Stent expansion.
Measured: Cohort A: 30 days Cohort B: 12 months
Edge dissection
Edge dissection.
Measured: Cohort A: 30 days Cohort B: 12 months
NIH percentage at the MLA
NIH (Neointimal hyperplasia) percentage at the MLA
Measured: Cohort A: 30 days Cohort B: 12 months
Percentage of Area stenosis at the MLA
Percentage of Area stenosis at the MLA.
Measured: Cohort A: 30 days Cohort B: 12 months
Luminal gain
Luminal gain (MLA post-procedure - MLA pre-procedure)
Measured: Cohort A: 30 days Cohort B: 12 months
In-stent late loss MLA
In-stent late loss MLA.
Measured: Cohort A: 30 days Cohort B: 12 months
In-segment (+5 mm from the stent edges) late loss (MLA)
In-segment (+5 mm from the stent edges) late loss (MLA).
Measured: Cohort A: 30 days Cohort B: 12 months
Proximal late loss (+5 mm from proximal stent edge) (MLA)
Proximal late loss (+5 mm from proximal stent edge) (MLA).
Measured: Cohort A: 30 days Cohort B: 12 months
Distal late loss (+5 mm from distal stent edge) (MLA)
Distal late loss (+5 mm from distal stent edge) (MLA).
Measured: Cohort A: 30 days Cohort B: 12 months
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: Cohort A: 30 days Cohort B: 12 months
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: Cohort A: 30 days Cohort B: 12 months
Percentage of Covered strut
Percentage of Covered strut (NIH thickness of >0 μm)
Measured: Cohort A: 30 days Cohort B: 12 months
Percentage of Healthy covered strut
Percentage of Healthy covered strut (NIH thickness≥40 μm)
Measured: Cohort A: 30 days Cohort B: 12 months
Peri-strut low intensity area
Peri-strut low intensity area (peri-strut region of homogeneous lower intensity observed without signal attenuation)
Measured: Cohort A: 30 days Cohort B: 12 months
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)
- Intraluminal mass (+4).
- Malposed and uncovered struts (+3).
- Uncovered struts alone (+2).
- Malposed struts alone (+1)
Measured: Cohort A: 30 days Cohort B: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start30 Aug 2022
- Primary completion30 Sep 2024
- Study completionDec 2029 (estimated)
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
- 60 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
- NCT05364697
- Sponsor's protocol ID
- IoNIR-001
- Acronym
- IonMAN
- Status last verified
- Nov 2024
- First submitted
- 3 May 2022
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IonMAN Trial-First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
- ClinicalTrials.gov ID
- NCT05364697
- Acronym / sponsor ID
- IonMAN / IoNIR-001
- Conditions
- Coronary Stenosis, Coronary Disease, Non-ST Elevated Myocardial Infarction, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medinol Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 May 2022 (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, First in Human clinical trial 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 (7 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 (36 listed)
- ST Segment Elevation MI within past 30 days.
- NSTEMI with biomarkers that have not peaked.
- Significant valvular disease or planned valvular intervention.
- PCI within the 30 days preceding the baseline procedure.
- PCI in the target vessel within 12 months of the baseline procedure.
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 SystemAlso: IoNIRThe 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. | Device | IoNIR Ridaforolimus-Eluting Coronary Stent |
Primary outcome
1In-stent Late Loss (LL)
Time frame: 1 year
In-stent Late Loss (LL) at 1 year (cohort B) assessed by quantitative coronary angiography (QCA) (Minimal Lumen Diameter (MLD) post-procedure - MLD follow-up)
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) at 1 year
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: Cohort A: 30 days Cohort B: 12 months
In-stent MLD
Time frame: Cohort A: 30 days Cohort B: 12 months
In-segment MLD
Time frame: Cohort A: 30 days Cohort B: 12 months
In-segment late loss
Time frame: Cohort A: 30 days Cohort B: 12 months
Proximal late loss
Time frame: Cohort A: 30 days Cohort B: 12 months
Distal late loss
Time frame: Cohort A: 30 days Cohort B: 12 months
In-stent and in-segment Binary Restenosis
Time frame: Cohort A: 30 days Cohort B: 12 months
OCT-determined inner layer percent neointimal hyperplasia volume
Time frame: Cohort A: 30 days Cohort B: 12 months
In-stent MLA
Time frame: Cohort A: 30 days Cohort B: 12 months
In-segment minimum lumen area
Time frame: Cohort A: 30 days Cohort B: 12 months
Minimal stent area
Time frame: Cohort A: 30 days Cohort B: 12 months
Stent expansion
Time frame: Cohort A: 30 days Cohort B: 12 months
Edge dissection
Time frame: Cohort A: 30 days Cohort B: 12 months
NIH percentage at the MLA
Time frame: Cohort A: 30 days Cohort B: 12 months
Percentage of Area stenosis at the MLA
Time frame: Cohort A: 30 days Cohort B: 12 months
Luminal gain
Time frame: Cohort A: 30 days Cohort B: 12 months
In-stent late loss MLA
Time frame: Cohort A: 30 days Cohort B: 12 months
In-segment (+5 mm from the stent edges) late loss (MLA)
Time frame: Cohort A: 30 days Cohort B: 12 months
Proximal late loss (+5 mm from proximal stent edge) (MLA)
Time frame: Cohort A: 30 days Cohort B: 12 months
Distal late loss (+5 mm from distal stent edge) (MLA)
Time frame: Cohort A: 30 days Cohort B: 12 months
Intraluminal mass at least 0.2 mm beyond the luminal edge of a strut
Time frame: Cohort A: 30 days Cohort B: 12 months
Malapposition
Time frame: Cohort A: 30 days Cohort B: 12 months
Percentage of Covered strut
Time frame: Cohort A: 30 days Cohort B: 12 months
Percentage of Healthy covered strut
Time frame: Cohort A: 30 days Cohort B: 12 months
Peri-strut low intensity area
Time frame: Cohort A: 30 days Cohort B: 12 months
Healing score
Time frame: Cohort A: 30 days Cohort B: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 2 countries: 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 Disease, run by Medinol Ltd. at 4 sites in 2 countries.
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 7 inclusion and 36 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, Brazil. 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?
This study is still under way. Results are not available in the source record yet.
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?
1In-stent Late Loss (LL) (time frame: 1 year). 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 21 Nov 2024.