NCT04558957已完成不适用
Prospective, Multi-centre Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With the Use of Flebogrif in Patients With Great Saphenous Vein Insufficiency
Balton Sp.zo.o.8 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年8月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Primary efficacy endpoint: Occlusion rate
研究概览
简要总结
The objective of the study is to collect clinical data of patients in whom Flebogrif® will have been used for mechanochemical ablation of incompetent veins in the follow-up period, as related to the safety, clinical effectiveness, properties and advantages of Flebogrif®.
The proposed study is a prospective, multi-centre clinical trial assessing the safety, efficacy and quality of Flebogrif® in a population of patients with the incompetent great saphenous vein, who require surgical treatment.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study inclusion criteria:
- •Signing the Informed Consent Form by the patient found eligible for the treatment with the mechanochemical method
- •The patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol
- •A patient with diagnosed varicose veins and diagnosed great saphenous vein (GSV) insufficiency confirmed by ultrasound (CEAP class C2-C6)
- •Favourable anatomy enabling the introduction of the Flebogrif® guidewire/catheter and positioning of its top part at the dedicated site (2-3 cm below SFJ)
- •Diameter of the treated vein of 4-10 mm
- •No data or no history indicating an allergy to the sclerosing chemicals used in the mechanochemical method (polidocanol), on the basis of the information obtained from the patient and the available medical records
- •No clinical symptoms indicating (chronic, critical) lower limb ischaemia precluding the use of compression, on the basis of a physical examination or, in unclear cases, of a Doppler ultrasound examination
- •No medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses
- •No cutaneous lesions (purulent, bullous) within the limb found eligible for treatment with the mechanochemical method
- •No clinical data indicating recent thrombosis within the deep vein system
- •No clinical data on diabetes with vascular complications
- •No clinical data indicating an active neoplastic process
排除标准
- •Recent deep vein thrombosis or occlusion
- •Congenital disorders with associated occlusion of deep system veins
- •Pregnancy and breast-feeding
- •Lower limb ischaemia
- •Severe lymphatic oedema
- •Bleeding diatheses
- •Documented allergic reaction to sclerosing chemicals used in mechanochemical vein ablation
- •Purulent dermatoses affecting the limb found eligible for treatment with mechanochemical vein ablation
- •Previous procedures on insufficiency veins of the superficial system
- •Acute infection
- •History of great saphenous vein thrombosis
- •End-stage kidney disease
结局指标
主要结局
Primary efficacy endpoint: Occlusion rate
时间窗: 3 months
Primary efficacy endpoint: Occlusion rate of the great saphenous vein in the treated segment at 3 months
Primary safety endpoint: Rate of SAE
时间窗: 30 days after the procedure
Primary safety endpoint: Rate of serious adverse events within 30 days after the procedure
次要结局
- Assessment of pain within 0-7 days after the procedure: Visual Analogue Scale(0-7 days after procedure)
- Period needed to resume normal activities(up to 2 years after the treatment)
- Number of Participants with no reflux in treated segment of the vein(1, 3, 6, 12, 18, 24 months)
- Period needed to return to work (sick leave period)(up to 2 years after the treatment)
- Clinical success - changes in rVCSS(12 and 24 months)
- Complications rate(up to 2 years after the treatment)
- Occlusion rate(1, 6, 12, 18, 24 months)
- Change in quality of life by Aberdeen Varicose Vein Questionnaire(12 and 24 months)
- Assessment of pain during the procedure(During procedure)
- Assessment of the need for analgesic treatment(0-7 days after procedure)
研究者
研究点 (8)
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