NL-OMON40842尚未招募不适用
VIRTUS - OUS Safety and Efficacy of the Veniti Vici* Venous Stent System (Veniti Inc.) when Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous Segment - VIRTUS - OUS
Veniti, Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >=18 years
- •2. Willing and capable of complying with all follow-up evaluations at the specified times
- •3. Able and willing to provide written informed consent prior to study specific procedures
- •4. Presence of unilateral, clinically significant, chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a >=50% reduction in target vessel lumen diameter as measured by venogram
- •5. Clinically significant venous obstruction defined as meeting at least one of the following clinical indicators:
- •Clinical severity class of CEAP classification >=3 (See Appendix 4.)
- •VCSS Pain Score >=2 (See Appendix 7.)
- •6. Negative pregnancy test in females of child-bearing potential
- •7. Intention to stent the target lesion only with the Veniti Vici* Venous Stent
排除标准
- •1. Presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment.
- •2. Venous obstruction that extends into the inferior vena cava
- •3. Contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof with planned treatment within 30 days after subject enrollment
- •4. Life expectancy <12 months
- •5. Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study
- •6. Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis
- •a. Uncorrected INR >=2.0 or aPTT >=1.5 X normal local lab value
- •b. Platelet count <100,000
- •c. Anti-platelet therapy except for ASA (patients on clopidogrel, prasugrel who cannot discontinue for seven days prior to the procedure are excluded)
- •7. Uncorrected hemoglobin of <=9 g/dL
- •8. Patients with an estimated glomerular filtration rate (eGFR) <30 mL/min
- •9. Known hypersensitivity to nickel or titanium
- •10. Contrast agent allergy that cannot be managed adequately with pre-medication
- •11. Intended concurrent thrombolysis or thrombectomy procedure OR intended or planned (within 30 days) adjuvant procedure such as creation of temporary AV fistula, placement of IVC filter, endovenectomy or saphenous vein ablation
- •12. Current or recent (within 30 days) active participation in another drug or device clinical trial
- •13. Patient judged to be a poor candidate by the primary investigator
- •14. Patient who does not consent to either the study treatment or study procedures, including follow-up visits
- •15. Patients who have had any prior surgical or endovascular procedure of the target vessel;Intra-procedural
- •1. Patients in whom the lesions cannot be traversed with a guide wire. These patients will not be enrolled and will not count against the study sample size.
- •2. Patients where the obstruction extends into the inferior vena cava. These patients will not be enrolled and will not count against the study sample size.
- •3. Patients whose vein diameters are not within limits stated in current Instructions for Use as determined by venogram. These patients will not be enrolled and will not count against the study sample size.
- •4. Patients who do not meet the venogram binary stenosis definition above, as determined by the treating physician.
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