Ongoing Registry of Deep Venous Reconstructions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in patency (primary, assisted primary and secondary) of the treated vein tracts assessed by duplex ultrasonography at regular time intervals.
研究概览
简要总结
Ongoing registration of deep venous obstructive disease patients treated by means of percutaneous transluminal angioplasty (PTA) and stenting with or without endophlebectomy (surgical desobstruction, also termed endovenectomy) of the common femoral vein and/or arteriovenous fistula creation.
详细描述
Literature has shown endovenous reconstructions to be safe en effective in treating deep venous obstructive disease. Deep venous obstruction can develop in cases of (iliac) vein compression syndromes (e.g. May-Thurner syndrome) or in cases of post-thrombotic syndrome. In patients with both significant complaints (objectively measured) and venous obstruction objectified on imaging (duplex ultrasonography, magnetic resonance venography, CT-venography) stenting is indicated.
In cases of extensive post-thrombotic damage to the veins of the lower extremity endophlebectomy (surgical desobstruction) of the common femoral vein can be warranted. This operation is generally combined with the creation of an arteriovenous fistula.
Data of patients treated in our tertiary medical centre are entered in a prospective digital database, and continuously updated.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Venous obstruction/occlusion in the femoral vein, common femoral vein, external iliac vein, common iliac vein or inferior vena cava
排除标准
- •Intolerance to anticoagulant medication
- •A life expectancy <1 year
结局指标
主要结局
Change in patency (primary, assisted primary and secondary) of the treated vein tracts assessed by duplex ultrasonography at regular time intervals.
时间窗: 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards
Patency is defined as the presence of bloodflow as imaged by use of duplex ultrasonography. Patency will be divided in 3 subgroups; primary patency, assisted primary patency and secondary patency. Primary patency is defined as presence of bloodflow during follow-up without any interventions undertaken to preserve or reclaim the openness of the treated vein segments. Assisted primary patency is defined as the presence of bloodflow during follow-up after use of an intervention to preserve the openness of the treated vein segments. Secondary patency is defined as the presence of bloodflow during follow-up after use of an intervention to reclaim the openness of the treated vein segments.
次要结局
- Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey.(Baseline, 12 and 52 weeks post-intervention, and yearly thereafter.)
- Change in QoL, assessed by Venous Insufficiency Epidemiological and Economic Study-quality of life/symptoms scales (VEINES-QoL/sym).(Baseline, 3 and 12 months post-intervention and yearly afterwards)
- Change in QoL, assessed by EuroQol 5 Dimensions (EQ-5D) questionnaire.(Baseline, 3 and 12 months post-intervention and yearly afterwards)
- Change in Venous Clinical Severity Score (VCSS).(Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards)
- Change in Villalta scale(Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards)
- Venous claudication; number of patients with presence or absence of venous claudication pre-intervention and post-intervention during follow-up.(Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards)