- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05364697
IonMAN Trial- First In Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System (IonMAN)
March 14, 2023 updated by: Medinol Ltd.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brenda Koltun Reuven
- Phone Number: 3277 972-3-767-9000
- Email: brendak@medinol.com
Study Locations
-
-
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Sao Paulo, Brazil
- Recruiting
- InCor
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Contact:
- Alexander Abizaid, Prof.
-
-
-
-
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Kfar Saba, Israel
- Recruiting
- Meir Medical Center
-
Contact:
- Abid Assali, Prof.
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Petah tikva, Israel
- Recruiting
- Rabin Medical Center
-
Contact:
- Hanna Vaknin Assa, Dr.
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Tel Aviv, Israel
- Recruiting
- Sourasky Medical Center
-
Contact:
- Maayan Konigstein, Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IoNIR Ridaforolimus-Eluting Coronary Stent
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 year
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac events
Time Frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
|
Major adverse cardiac events (MACE; the composite rate of cardiovascular death, any MI or ischemia-driven target lesion revascularization (TLR))
|
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
|
All-cause mortality.
|
30 days, 6 months, 1, 2, 3, 4, 5 years
|
Cardiovascular death
Time Frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
|
Cardiovascular death.
|
30 days, 6 months, 1, 2, 3, 4, 5 years
|
Myocardial infarction
Time Frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
|
Myocardial infarction.
|
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 vessel related MI.
|
30 days, 6 months, 1, 2, 3, 4, 5 years
|
Target Lesion Failure
Time Frame: 6 months, 2, 3, 4, 5 years
|
Target Lesion Failure (TLF)
|
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 Lesion Revascularization
|
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
|
Ischemia-driven Target Vessel Revascularization.
|
30 days, 6 months, 1, 2, 3, 4, 5 years
|
Stent thrombosis
Time Frame: 30 days, 6 months, 1, 2, 3, 4, 5 years
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Stent thrombosis (ARC-2 definite and probable)
|
30 days, 6 months, 1, 2, 3, 4, 5 years
|
Acute Device Success
Time Frame: index procedure
|
Acute Device Success (successful crossing and deployment with residual QCA DS <30%).
|
index procedure
|
Luminal gain
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Luminal gain (MLD post-procedure - MLD pre-procedure).
|
Cohort A: 30 days Cohort B: 12 months
|
In-stent MLD
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
In-stent Minimal Lumen Diameter
|
Cohort A: 30 days Cohort B: 12 months
|
In-segment MLD
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
In-segment (+5mm from the stent edges) MLD
|
Cohort A: 30 days Cohort B: 12 months
|
In-segment late loss
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
In-segment (+5mm from the stent edges) late loss
|
Cohort A: 30 days Cohort B: 12 months
|
Proximal late loss
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Proximal late loss (+5 mm from proximal stent edge)
|
Cohort A: 30 days Cohort B: 12 months
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Distal late loss
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Distal late loss (+5 mm from distal stent edge)
|
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
|
In-stent and in-segment Binary Restenosis.
|
Cohort A: 30 days Cohort B: 12 months
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OCT-determined inner layer percent neointimal hyperplasia volume
Time Frame: Cohort A: 30 days Cohort B: 12 months
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CT-determined inner layer percent neointimal hyperplasia volume.
|
Cohort A: 30 days Cohort B: 12 months
|
In-stent MLA
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
In-stent Minimum Lumen Area
|
Cohort A: 30 days Cohort B: 12 months
|
In-segment minimum lumen area
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
In-segment minimum lumen area (MLA)
|
Cohort A: 30 days Cohort B: 12 months
|
Minimal stent area
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Minimal stent area (MSA)
|
Cohort A: 30 days Cohort B: 12 months
|
Stent expansion
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Stent expansion.
|
Cohort A: 30 days Cohort B: 12 months
|
Edge dissection
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Edge dissection.
|
Cohort A: 30 days Cohort B: 12 months
|
NIH percentage at the MLA
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
NIH (Neointimal hyperplasia) percentage at the MLA
|
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
|
Percentage of Area stenosis at the MLA.
|
Cohort A: 30 days Cohort B: 12 months
|
Luminal gain
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Luminal gain (MLA post-procedure - MLA pre-procedure)
|
Cohort A: 30 days Cohort B: 12 months
|
In-stent late loss MLA
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
In-stent late loss MLA.
|
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
|
In-segment (+5 mm from the stent edges) late loss (MLA).
|
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
|
Proximal late loss (+5 mm from proximal stent edge) (MLA).
|
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
|
Distal late loss (+5 mm from distal stent edge) (MLA).
|
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
|
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)
|
Cohort A: 30 days Cohort B: 12 months
|
Malapposition
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
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)
|
Cohort A: 30 days Cohort B: 12 months
|
Percentage of Covered strut
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Percentage of Covered strut (NIH thickness of >0 μm)
|
Cohort A: 30 days Cohort B: 12 months
|
Percentage of Healthy covered strut
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Percentage of Healthy covered strut (NIH thickness≥40 μm)
|
Cohort A: 30 days Cohort B: 12 months
|
Peri-strut low intensity area
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
Peri-strut low intensity area (peri-strut region of homogeneous lower intensity observed without signal attenuation)
|
Cohort A: 30 days Cohort B: 12 months
|
Healing score
Time Frame: Cohort A: 30 days Cohort B: 12 months
|
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)
|
Cohort A: 30 days Cohort B: 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2022
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2028
Study Registration Dates
First Submitted
May 3, 2022
First Submitted That Met QC Criteria
May 3, 2022
First Posted (Actual)
May 6, 2022
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IoNIR-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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