NCT05364697进行中（未招募）不适用
IonMAN Trial-First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Medinol Ltd.
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- 1In-stent Late Loss (LL)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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/mm
- •White blood cell (WBC) count <3,000 cells/mm
- •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
结局指标
主要结局
1In-stent Late Loss (LL)
时间窗: 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
时间窗: 1 year
Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year
次要结局
- Distal late loss(Cohort A: 30 days Cohort B: 12 months)
- In-stent and in-segment Binary Restenosis(Cohort A: 30 days Cohort B: 12 months)
- Target vessel related MI(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)
- OCT-determined inner layer percent neointimal hyperplasia volume(Cohort A: 30 days Cohort B: 12 months)
- In-stent MLA(Cohort A: 30 days Cohort B: 12 months)
- All-cause mortality(30 days, 6 months, 1, 2, 3, 4, 5 years)
- Myocardial infarction(30 days, 6 months, 1, 2, 3, 4, 5 years)
- Target Lesion Failure(6 months, 2, 3, 4, 5 years)
- Ischemia-driven TLR(30 days, 6 months, 1, 2, 3, 4, 5 years)
- Stent thrombosis(30 days, 6 months, 1, 2, 3, 4, 5 years)
- In-stent MLD(Cohort A: 30 days Cohort B: 12 months)
- In-segment MLD(Cohort A: 30 days Cohort B: 12 months)
- Major adverse cardiac events(30 days, 6 months, 1, 2, 3, 4, 5 years)
- Cardiovascular death(30 days, 6 months, 1, 2, 3, 4, 5 years)
- NIH percentage at the MLA(Cohort A: 30 days Cohort B: 12 months)
- Acute Device Success(index procedure)
- Stent expansion(Cohort A: 30 days Cohort B: 12 months)
- Percentage of Covered strut(Cohort A: 30 days Cohort B: 12 months)
- Percentage of Healthy covered strut(Cohort A: 30 days Cohort B: 12 months)
- In-segment late loss(Cohort A: 30 days Cohort B: 12 months)
- Proximal late loss(Cohort A: 30 days Cohort B: 12 months)
- In-segment minimum lumen area(Cohort A: 30 days Cohort B: 12 months)
- Minimal stent area(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)(Cohort A: 30 days Cohort B: 12 months)
- Edge dissection(Cohort A: 30 days Cohort B: 12 months)
- In-stent late loss MLA(Cohort A: 30 days Cohort B: 12 months)
- Percentage of Area stenosis at the MLA(Cohort A: 30 days Cohort B: 12 months)
- Malapposition(Cohort A: 30 days Cohort B: 12 months)
- Peri-strut low intensity area(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)
- Intraluminal mass at least 0.2 mm beyond the luminal edge of a strut(Cohort A: 30 days Cohort B: 12 months)
- Healing score(Cohort A: 30 days Cohort B: 12 months)
- Luminal gain(Cohort A: 30 days Cohort B: 12 months)
研究者
研究点 (4)
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