SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 89
- 试验地点
- 8
- 主要终点
- Primary Efficacy Endpoint - Proportion of Responders
研究概览
简要总结
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
详细描述
To compare safety and efficacy of SakuraBead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on a total of approximately 89 patients who will be followed up for a period of 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able and willing to provide written informed consent, and
- •Clinical diagnosis of knee OA, and
- •Moderate to severe knee pain (WOMAC Pain ≥ 10), and
- •Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
- •Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
- •Age ≥ 40 years and < 80 years, and
- •Able to comply with all treatments and follow-up visits.
排除标准
- •Severe knee OA (Kellgren-Lawrence grade 4), or
- •Current infection of target joint, or
- •Life expectancy less than 36 months, or
- •Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
- •Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
- •Prior knee replacement surgery in the target knee, or
- •Pain score of >3 NRS on the non-target knee, or
- •An acute internal derangement of the target knee, or
- •History of uncorrectable coagulopathy, or
- •Prior iodinated contrast reaction resulting in anaphylaxis, or
- •Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
- •Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or
- •Contraindication to MRI, or
- •At the discretion of the Principal Investigator
研究组 & 干预措施
Genicular Artery Embolization (GAE)
Temporary Embolization of Genicular Arteries using Resorbable Microspheres
干预措施: SakuraBead Resorbable Microspheres (Device)
Corticosteroid Injection
Corticosteroid injection in the knee
干预措施: Corticosteroid Injection (Drug)
结局指标
主要结局
Primary Efficacy Endpoint - Proportion of Responders
时间窗: 6 Months
Compare the proportion of responders\* (defined as ≥50% reduction in WOMAC Pain\*\* score and ≥2 point reduction in NRS\*\*\*) between the Investigational procedure and Control at 6 months. * Non-responders will include subjects experiencing device-related SAEs. \*\*Western Ontario and McMaster Universities Osteoarthritis Pain Index. Scale: 0-20, where a lower score represents a better outcome \*\*\*NRS: Numeric Rating Scale that measures pain from 0 (no pain) to 10 points (worst pain).
Primary Safety Endpoint - Freedom from treatment-related SAEs
时间窗: 6 Months
Freedom from treatment-related serious adverse events (SAE) through 6 months following the index procedure (proportions will be compared between Investigational procedure and Control).
次要结局
- Proportion of Responders at 1 Month and 3 Month(1 Month and 3 Months)
- Change in mean WOMAC Pain(1 Month, 3 Months and 6 Months)
- Change in Numeric Rating Scale (NRS)(1 Month, 3 Months and 6 Months)