NCT07747883尚未招募不适用
First-in-Human Use of the IV-X Medical Intravascular Lithotripsy System in Patients With Peripheral Artery Disease
IVX Medical0 个研究点目标入组 25 人开始时间: 2026年9月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Primary Safety Endpoint defined as proportion of subjects with one or more new onset Major Adverse Events (MAEs) through 30 days post-procedure.
研究概览
简要总结
To evaluate the safety and performance of the IV-X Medical Intravascular Lithotripsy (IVL) System in adults in order to demonstrate the ability of the IV-X Medical IVL System to safely and effectively deliver IVL treatment calcified peripheral arteries (iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries).
详细描述
IV-X Medical is conducting a prospective, single-arm, single-center clinical premarket study to evaluate the safety and effectiveness of the IV-X Medical IVL System to treat moderately to severely calcified peripheral arteries in the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries. Up to 25 subjects will be enrolled.
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
- •Eligibility criteria are differentiated, where appropriate, by lesion location of above-the-knee (ATK) or below-the-knee (BTK).
- •Standard Inclusion Criteria:
- •Age of subject is >
- •Rutherford Clinical Category:
- •ATK: 2, 3, or 4
- •BTK: 4 or 5 (Category 5 will only include patients with ulcers not extending proximal to the metatarsal head)
- •Estimated life expectancy >1 year in the opinion of the investigator at the time of enrollment.
- •Subject or subject's legal representative agrees to participate and comply with the study assessments.
- •Angiographic Inclusion Criteria:
- •Subject is a suitable candidate for angiography and endovascular intervention, in the opinion of the investigator or per hospital guideline.
- •De novo target lesion that is located in a native vessel as follows:
- •ATK: Iliac, superficial femoral artery (SFA), popliteal artery (extends to 2cm above the bifurcation or trifurcation of the tibial artery)
- •BTK: distal segment (P3) of the popliteal artery to the ankle joint
- •Target lesion reference vessel diameter is between the following sizes by visual estimate:
- •ATK: 3.5mm and 12.0mm
- •BTK: 2.0mm and 5.0mm
- •Target lesion stenosis ≥70% via visual estimate.
- •Subject has at least:
- •ATK: One (1) patent contiguous vessel with runoff to the foot (not supported by collateral circulation) in the target leg. Vessel patency is defined as no stenosis >50%.
- •BTK: Distal constitution of one (1) pedal vessel (< 50% stenosis) (desert foot excluded).
- •Ability to pass the guidewire intraluminally by Investigator evaluation across the atherosclerotic lesion, without the use of re-entry devices.
- •Calcification is at least moderate with visual evidence of calcification and at least one: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.
- •Successful treatment without complications (≤ 30% residual stenosis) of significant stenosis or occlusion of inflow tract proximal to the target treatment zone using percutaneous angioplasty or stent, if applicable (no IVL).
排除标准
- •Rutherford Clinical Category 0, 1, or 5 with ulcers extending proximal to the metatarsal head, Category 6, or physically unable to ambulate (e.g., bedridden).
- •Subject has active infection requiring IV antibiotics in the target leg.
- •Planned major amputation of the target leg (above the ankle joint or higher).
- •Prior endovascular or surgical procedure on the index limb within the 30 days prior to enrollment (including thrombolysis).
- •Subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet count less than 100,000/microliter, or international normalized ratio >1.5 at the time of enrollment.
- •Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- •Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- •Myocardial infarction within 60 days prior to enrollment.
- •Stroke within 60 days prior to enrollment.
- •History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
- •Subject has acute or chronic renal disease (serum creatinine of >2.5 mg/dL or eGFR <30) or is on dialysis at the time of enrollment.
- •Presence of venous insufficiency with history of venous ulceration in the target limb in the past year.
- •Subject is pregnant or nursing.
- •Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
- •Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment.
- •Angiographic Exclusion Criteria:
- •Any stent within the target lesion
- •Target lesion(s) within native or synthetic vessel grafts.
- •Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
- •Use of: (1) CTO re-entry or (2) other non-study IVL devices on the target lesion.
- •Lesions within 10mm of the ostium of the SFA
- •Evidence of aneurysm or acute thrombus in target vessel.
研究组 & 干预措施
IVL Treatment Arm
Experimental
干预措施: IV-X Medical IVL System (Device)
结局指标
主要结局
Primary Safety Endpoint defined as proportion of subjects with one or more new onset Major Adverse Events (MAEs) through 30 days post-procedure.
时间窗: 30 Days
Major Adverse Events (MAEs) are defined as: * Clinically driven target limb revascularization * Unplanned amputation of the target limb above the ankle * Device- or procedure-related post-operative death
Primary Effectiveness Endpoint defined as the number of subjects with post-procedure residual diameter stenosis of <50% (after adjunctive therapy, if used), as assessed by quantitative angiography.
时间窗: Day of procedure
次要结局
- Change in ankle-Brachial Index (ABI) and/or toe-Brachial Index (TBI) of the target limb at 30 days, compared to Baseline.(30 Days)
- Secondary Endpoint of Acute Procedural Success with Freedom from Procedural Major Adverse Events.(Day of Procedure)
- Secondary Endpoint of Acute Procedural Success defined as number of procedures with successful IVL treatment delivery in desired location using 2 or fewer catheters.(Day of Procedure)
- Secondary Safety Endpoint defined as the proportion of subjects with one or more device- or procedure-related adverse events (AEs) or serious adverse events (SAEs) through 30 days post-procedure.(30 Days)
- Secondary Safety Endpoint defined as freedom from clinically driven target lesion revascularization (TLR-lesion) at 30 days.(30 Days)
- Change in Rutherford Clinical Category score at 30 days, compared to Baseline.(30 Days)
- Secondary Endpoint for Treatment Effectiveness defines as number of patients with target lesion patency - freedom from ≥50% restenosis at 30 days post-procedure (vessel is patent and duplex ultrasound peak systolic velocity ratio ≥2.4).(30 Days)
- Secondary Endpoint of Procedural Success defined as the number of procedures with successful crossing of below-the-knee (BTK) lesions without adjunctive pre-dilation.(Day of Procedure)
研究者
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