NCT05355688招募中不适用
Prospective, Single-centre Post-Market Clinical Follow-up (PMCF) Study to Evaluate Safety and Performance of the DUO Venous Stent
Klinikum Arnsberg1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月6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
- 20
- 试验地点
- 1
- 主要终点
- Primary patency rate at month 12
研究概览
简要总结
This observational study is to evaluate performance and safety of the DUO Venous Stent for the treatment of obstructions of the iliac vein.
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
- •Patient is willing and able to provide inform consent
- •Patients must be ≥ 18 years of age at the time of consent
- •Estimated life expectancy ≥ 12 months.
- •Body mass index (BMI) <35
- •Patients to whom the DUO Venous Stent can be implanted according to the IFU (this includes acute iliac deep vein thrombosis (DVT), post-thrombotic syndrome, non-thrombotic iliac vein compression (e.g. May-Thurner), non-thrombotic iliac vein compression (e.g. compression from ecstatic or tortuous iliac arteries))
- •As per IFU, clinically significant symptomatic venous outflow obstruction in the iliac venous segment, associated by at least one of the following:
- •CEAP score ≥3
- •VCSS pain score ≥2
- •Subject is willing and able to comply with physician's recommendation for compression therapy -
排除标准
- •Presence or history of clinically significant pulmonary emboli within 180 days prior to enrolment.
- •Uncontrolled or active coagulopathy or known, incorrectable bleeding diathesis
- •Prior surgical or endovascular procedure of the target vessel except for catheter-directed or mechanical thrombolysis for DVT within 90 days prior to the index procedure or prior venoplasty
- •Planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or 30 days after the index procedure
- •Previous stenting of the target vessel
- •Combination of stents from different manufacturers
- •Participation in another investigational study in which the subject has not completed all primary endpoints or which involves any investigational drug or device that may potentially confound the results of the study
- •Other comorbidities that, in the opinion of the investigator, would preclude the patient from receiving this treatment and/or participating in study-required follow-up assessments
- •Women who are pregnant or lactating
- •Suspected alcohol or drug abuse
- •Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
结局指标
主要结局
Primary patency rate at month 12
时间窗: 12 months
The primary patency rate is defined as the percentage of stented target lesions with primary treatment success and without the occurrence of thrombosis of the treated lesion or any re-intervention (surgical interventions on the target vessel) to restore or maintain flow within the treated lesion
次要结局
- Primary patency rates(30 Days, 6 and 24 months)
- Revised Venous Clinical Severity Score (VCSS)(30 Days 6, 12 and 24 month)
- Secondary patency rates(30 Days, 6, 12 and 24 months)
- Villalta score(30 Days, 6, 12 and 24 month)
- Serious adverse events(30 Days, 6, 12 and 24 month)
- Clinical Etiological Anatomical Pathophysiological Classification score (CEAP)(30 Days, 6, 12 and 24 months)
- Device or procedure-related adverse events(30 Days, 6, 12 and 24 month)
研究者
研究点 (1)
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