NL-OMON47346已完成不适用
The BARD® VENOVO * Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease * an Assessment for Effectiveness and Safety (VERNACULAR) - Venous Stent Study - VERNACULAR
C. R Bard0 个研究点目标入组 34 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
- 已完成
- 发起方
- 入组人数
- 34
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. The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) / Institutional Review Board (IRB) for the site.
- •2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- •3. The subject is a male or non-pregnant female * 18 years old with an expected lifespan sufficient to allow for completion of all study procedures. Female subjects of childbearing potential must have a negative pregnancy test (urine or blood) within 14 days prior to the index procedure.
- •4. The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral *venous segments* (unilateral obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof) of * 50% as determined by catheter contrast venography.
- •5. The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral venous segments with a Clinical-Etiology-Anatomic-Pathophysiologic Score CEAP *C* * 3 or a Venous Clinical Severity Score VCSS pain score of * 2.
- •6. The subject is able and willing to comply with any required medication regimen.
- •7. The reference vessel diameter(s) (RVD) is (are) between 7mm and 19mm as determined by the Investigator*s visual estimate.
排除标准
- •1. The subject is unable or unwilling to provide written informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits. ;2. The subject is or plans to become pregnant during the study.
- •3. The subject has contralateral disease of the common femoral vein,
- •external iliac vein, common iliac vein, or any combination thereof and
- •does not meet the venous outflow obstruction requirement as
- •determined by the treating Investigator or the target vessel has a
- •malignant obstruction.
- •4. The subject is asymptomatic, has a CEAP *C* <3, or a VCSS pain
- •score of <2.
- •5. The subject has a venous obstruction that extends into the inferior vena
- •cava (IVC) or below the level of the lesser trochanter.
- •6. The subject has a known uncorrectable bleeding diathesis or active
- •coagulopathy.
- •7. The subject has a known allergy or sensitivity to Nickel or Titanium or
- •has intolerance to antiplatelet, anticoagulant or thrombolytic
- •medications required per the protocol
- •8. The subject has a known allergy or sensitivity to contrast media, which
- •cannot be adequately pre-medicated.
- •9. The subject has any planned surgical interventions (other than pre-
- •stenting procedures of thrombolysis, thrombectomy, and/or vena cava
- •filter placement in patients at high risk for pulmonary embolism)
- •within 30 days prior to, or within 30 days after the planned study
- •10.The subject has a lesion(s) or occlusion(s) which cannot be traversed
- •with a guidewire.
- •11.The subject has had prior stenting in the target vessel.
- •12.The subject has iliofemoral venous segments unsuitable for treatment
- •with available sizes of study devices.
- •13.The subject has another medical condition, which, in the opinion of
- •the Investigator, may cause him/her to be non-compliant with the
- •protocol, confound the data interpretation, or is associated with a life
- •expectancy insufficient to allow for the completion of study
- •procedures and follow-up.
- •14.The subject is currently participating in an investigational drug,
- •biologic, or another device study for which the investigational
- •treatment has not ended. Studies requiring extended follow-up for
- •products that are now commercially available are not considered
- •investigational studies.
- •15.The subject is currently on dialysis or has a serum creatinine * 2.5
研究者
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