Prospective Observational Study of Procedures With MicroNet Covered Stent Use to Treat Increased Risk Lesions in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of procedural success
研究概览
简要总结
Prospective observational study of MicroNet covered stent implantation in the elevated risk peripheral lesions (high lesion load, thrombus containing, highly calcified).
Open-label, non randomized, single arm observational study. Jagiellonian University Medical College research project.
详细描述
Peripheral artery stents in routine use (both balloon expandable and self-expendable) do not sufficiently prevent distal embolization. They might induce a "cheese-grater" effect - a consequence of their single layer design with uncovered space between stent struts.
Aim of the study is to evaluate short and long term safety and efficacy of MicroNet covered stent implantation in the high risk lesions beyond the carotid bifurcation. Treatment eligibility will be evaluated by a Vascular Team process (angiologist, vascular surgeon, cardiologist). Optimal pharmacotherapy will be administered according to the current guidelines.
Symptomatic and asymptomatic patients with peripheral artery disease requiring endovascular treatment for high risk stenosis (soft plaque, highly calcific plaque) per Vascular Team assessment.
A group of 30-50 consecutive patients meeting inclusion and exclusion criteria will be enrolled.
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
- •Patients older than 18 years, eligible for peripheral artery stenting after Vascular Team evaluation, according to local standards
- •Written, informed consent to participate
- •Agreement to attend protocol required (standard) follow up visits and examinations
排除标准
- •Life expectancy <1 year (e.g. active neoplastic disease).
- •Chronic kidney disease with creatinine > 3.0 mg/dL.
- •Myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure)
- •Pregnancy (positive pregnancy test)
- •Coagulopathy.
- •History of uncontrolled contrast media intolerance
- •Angiographic
- •Inclusion Criteria:
- •De novo lesion in major arteries or grafts connecting arteries
- •Stenosis eligible for endovascular treatment per Vascular Team evaluation (according to current standards and guidelines)
- •High risk morphology stenosis (per 2 independent, experienced operators)
- •Exclusion Criteria:
- •Chronic total occlusion not amenable to re-canalization
- •Stent in the target vessel/lesion
- •Anatomic variants precluding stent implantation
- •Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion
结局指标
主要结局
Rate of procedural success
时间窗: Up to 48 hours after procedure or until hospital discharge, whichever came first.
Procedural success, defined as technical success (successful delivery and implantation of the stent) AND residual stenosis ≤ 30% of vessel lumen diameter AND clinical success (no peri-procedural complications)
次要结局
- Number of MACNE at 30 days(At 30 days after procedure)
- Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at discharge(24 hours after procedure)
- Vessel patency in CT angiography at 6 months(At 6 months after procedure)
- Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events)(Up to 48 hours after procedure or until hospital discharge, whichever came first.)
- Number of MACNE at 6 months(At 6 months after procedure)
- Rate of peri-procedural complications(Up to 48 hours after procedure)
- Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel at 12 months(At 12 months after procedure)
- Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at 6 months(At 6 months after procedure)