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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 41
- 主要终点
- Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure
研究概览
简要总结
The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease.
详细描述
This is a prospective, multi-center, non-randomized, single-arm clinical study of the VENOVO ™ Venous Stent for the treatment of iliofemoral occlusive disease. The study will be conducted at a maximum of 35 investigational sites ("sites") in the United States, and Europe and Australia/New Zealand. Enrollment will continue until a maximum of one hundred seventy (170) subjects are treated with the VENOVO™ Venous Stent, which is an estimated three-hundred forty (340) consecutive subjects in a non-randomized fashion. It is assumed that approximately 50% of the treated subjects will be U.S. subjects. Clinical follow-up for all treated subjects will be performed at hospital discharge, 30-days, and 6-, 12-, 24-, and 36-months post-index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The subject provides written informed consent using an Informed Consent Form approved by Ethics Committee/ Institutional Review Board for the site.
- •Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- •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.
- •The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral "venous segments".
- •The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral venous segments(Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) "C" ≥ 3 or VCSS pain score of ≥ 2).
- •The subject is able and willing to comply with any required medication regimen.
- •The reference vessel diameters are between 7mm and 19 mm.
排除标准
- •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.
- •Subject is or plans to become pregnant during the study.
- •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 or has a malignant obstruction.
- •The subject is asymptomatic, has a CEAP "C" <3, or a VCSS pain score of <
- •The subject has a venous obstruction that extends into the inferior vena cava (IVC) or below the level of the lesser trochanter.
- •The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
- •The subject has a known allergy or sensitivity to Nickel or Titanium or intolerance to antiplatelet, anticoagulant or thrombolytic medications medications required per the protocol
- •The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
- •The subject has any planned surgical interventions within 30 days prior to, or within 30 days after the planned study procedure.
- •The subject has a lesion or occlusion which cannot be traversed with a guidewire.
- •The subject has had prior stenting in the target vessel.
- •The subject has iliofemoral venous segments unsuitable for treatment with available sizes of study devices.
- •The subject has another medical condition, which 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 completion of study procedures and follow ups.
- •The subject is currently participating in an investigational drug, biologic, or another device study.
- •The subject is currently on dialysis or has a serum creatinine ≥2.5mg/dl.
结局指标
主要结局
Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure
时间窗: 12 months post-index procedure
Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis \> 50% as measured by Duplex Ultrasound (DUS). Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.
Number of Participants With Freedom From Major Adverse Events (MAEs)
时间窗: 30 days post-index procedure
Freedom from major adverse events (MAEs) defined as: Target Vessel Revascularization; Device and/or procedure related death; Major amputation of target limb; Pulmonary Embolism which is clinically important; Vascular injury requiring surgical/endovascular intervention; Embolization /migration of stent; Device or procedure related acute DVT involving the treated limb. Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.
次要结局
- Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure(Evaluation through 30 day, 6 months and 12 months post index procedure)
- Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months(Evaluation at 12 months post-index procedure)
- Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months(Evaluation at 12 months post-index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects)(At the conclusion of index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects)(Evaluation throrugh 30 day, 6 months and 12 months post index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects)(Evaluation through 30 days, 6 months and 12 months post index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success(At time of Index Procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)(Less than 30 days post index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up(Evaluation at 12 months post-index procedure)