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) - VERNACULAR
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 170
研究概览
简要总结
The primary effectiveness endpoint of the study was primary patency at 12 months postindex procedure, defined as: freedom from TVR; freedom from thrombus occlusion and stenosis > 50% as measured by DUS. The primary effectiveness endpoint was evaluated against a literature-derived PG of 74%, which was set at 10% (non-inferiority margin) below the weighted mean of primary patency rate at 12 months at a combination of 55% PTS subjects at primary patency rate of 77.1% and 45% NIVL subjects at primary patency rate of 93.4%. The final 12-month weighted primary patency rate in the VENOVO™Venous Stent group was 88.6% with 90% CI [82.8%,94.4%] a statistically significant difference from a literature derived PG of 74% (one-sided p-value <0.0001). To demonstrate acceptable safety, the primary safety endpoint was evaluated against the PG of 89% which was set at 10% (non-inferiority margin) below the literature-derived average freedom from MAE rate at 30 day of 99%. The proportion of subjects free from primary safety events was 93.5% with 90% CI [89.5%,96.3%], a statistically significant difference from a literature-derived PG of 89% (one-sided p-value = 0.0322). The VERNACULAR study results provide scientific evidence that the VENOVO™Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous outflow obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
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 (nonmalignant) 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 procedure.
- •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 rotocol, 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 mg/dl.