NCT02799914撤回不适用
Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease: A Monocenter Post Market Clinical Follow-up Study
be Medical1 个研究点 分布在 1 个国家开始时间: 2016年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Stent patency
研究概览
简要总结
Post market clinical follow-up study about the Sinus-venous stent. Patients with venous iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational study will provide 1 year data about safety and efficacy.
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
- •Age at study entry is at least 18 years.
- •Patient must sign the informed consent form prior to the index-procedure.
- •Patient suffers from acute or chronic venous occlusive disease indicated to be treated with a venous stent.
- •Target lesion is located in the femoral vein, common femoral vein, external iliac vein, or common iliac vein.
排除标准
- •Intolerance to anticoagulant medication.
- •Contra-indication for prolonged anticoagulant treatment.
- •Life expectancy less than 1 year.
- •Target vessel has been stented before.
- •Coagulopathy or known uncorrectable bleeding diathesis.
- •Recent (<1 year) pulmonary embolism.
- •Known hypersensitivity to nitinol and/or nickel.
- •Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
- •Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study.
- •Patients in custody by juridical order.
- •Patients who do not agree to the transmission of their coded data within the liability of documentation and notification.
- •Close affiliation with the investigational site: e.g. a close relative of the investigator or a possibly dependent person (e.g. employee or student of the investigational site).
结局指标
主要结局
Stent patency
时间窗: 12 months
Patency broken down in primary patency, assisted primary patency and secondary patency
次要结局
- Technical success(Index-procedure (intraoperative))
- Revised venous clinical severity score(12 months)
- Mortality(12 months)
- Procedural complications(Index-procedure)
- Reintervention(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Post-Market Clinical Follow-up (PMCF) Study to Evaluate Safety and Performance of the DUO Venous StentDeep Venous ObstructionsNCT05355688Klinikum Arnsberg20
已完成
不适用
Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS StudyIliac Vein Compression SyndromePost-thrombotic SyndromeNCT02942394Optimed Medizinische Instrumente GmbH60
终止
不适用
The eSVS® Mesh Randomized Post-Market StudyCoronary DiseaseHeart DiseasesCardiovascular DiseasesArterial Occlusive DiseasesVascular DiseasesArteriosclerosisCoronary Artery DiseaseMyocardial IschemiaNCT01462721Kips Bay Medical, Inc.12
Unknown
不适用
Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial HypertensionIdiopathic Intracranial HypertensionNCT05308823Al-Azhar University20
已完成
不适用
Stenting of venous sinus stenosis for medically refractory idiopathic intracranial hypertensioBenign intracranial hypertensionIdiopathic intracranial hypertensionISRCTN13784335CHU de Québec33