NCT04743180招募中不适用
European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.
iVascular S.L.U.15 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年1月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 15
- 主要终点
- Primary Endpoint Efficacy measured by presence of primary patency of the target lesion based on ultrasound images
研究概览
简要总结
The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18 years of age
- •Rutherford Clinical Category 2-5
- •The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF)
- •Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery
- •TASC II Class A to D Lesions
- •de novo lesion(s), non-stented or stented restenotic lesion(s)
- •Proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation
- •Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk (P3)
- •A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication
- •Successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; Use of crossing devices allowed if necessary. Use of laser or atherectomy is allowed if necessary, during the index procedure. Bailout stenting is allowed if necessary, after DEB use
- •At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is NOT permitted during the index procedure)
排除标准
- •Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
- •Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU)
- •Life expectancy of < 1year
- •Patient is currently participating in an investigational drug or other device study or previously enrolled in this study
- •Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
- •Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel
结局指标
主要结局
Primary Endpoint Efficacy measured by presence of primary patency of the target lesion based on ultrasound images
时间窗: 12 Months
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis.
Overall Medical Safety
时间窗: 36 Months
Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 3 years from the following: index limb amputation (above or below the ankle), and all-cause mortality (with a detailed analysis of cardiovascular (CV) and non-CV deaths). Success is defined as freedom from all specified events; failure is defined as one or more specified events occurrences.
次要结局
- Secondary Endpoint Medical Safety: Major vascular complications(≤30 days after index procedure)
- Secondary Endpoint Medical Safety: Composite Safety(1, 6, 12, 36, 48, 60 months after index procedure)
- Secondary Endpoint Efficacy: Acute Device Success(During index procedure)
- Secondary Endpoint Efficacy: Technical Success(During index procedure)
- Secondary Endpoint Medical Safety: All-cause death(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Medical Safety: Target Vessel Revascularization (TVR)(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Efficacy: Change of resting Ankle Brachial Index (ABI) from baseline(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Medical Safety: Major amputation at target limb(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Medical Safety: Minor amputation at target limb(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Medical Safety: Target Limb Reintervention(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Efficacy: Procedural Success(Up to 30 days)
- Secondary Endpoint Efficacy: Primary Patency(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Efficacy: Secondary Patency(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Efficacy: Target Lesion Revascularization (TLR)(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Efficacy: Clinically-driven Target Lesion Revascularization (TLR)(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Efficacy: Change of Rutherford classification from baseline(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Efficacy: Change in Walking Impairment Questionnaire from baseline(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Efficacy: Change in quality of life from baseline, as measured by EQ-5D(1, 6, 12, 24, 36, 48, 60 months after index procedure)
- Secondary Endpoint Cost-Effectiveness (optional): factoring procedure and hospital admission costs(1, 6, 12, 24, 36, 48, 60 months after index procedure)
研究者
研究点 (15)
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