NCT01746550已完成不适用
A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent.
C. R. Bard12 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 12
- 主要终点
- The proportion of subjects who are free of target limb failure at 12-months post study procedure.
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford Category 2-4 (mild intermittent claudication (pain while walking)to ischemic pain (pain due to decreased blood flow) at rest).
- •The target lesion(s) has evidence of narrowing or blockage and can be stented.
- •The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm.
- •The target vessel reference diameter is greater than or equal to 4.0 mm and less than or equal to 6.5 mm
排除标准
- •The subject has a known reaction (including allergic reaction) or sensitivity to blood thinning medications, or study device materials (nickel, titanium or tantalum)
- •The subject has a known sensitivity to medical imaging substances (contract media) that cannot be pretreated with medications (steroids or/and antihistamines)
- •The subject has a history of bleeding disorders (diatheses or coagulopathy).
- •The subject has kidney failure or is having dialysis treatment.
- •The subject has insufficient liver function, swelling of vein(s) caused by blood clot (thrombophlebitis), uremia, systemic lupus, or deep vein blood clots.
- •Subject has Acute Limb Ischemia (a sudden loss of blood flow to the limb).
- •Subject has a history of bypass surgery on the study vessel.
- •Subject has a history of heart attack or stroke within 6 months of study procedure.
- •The subject is receiving immunosuppressive therapy (medications that lower the body's normal immune response).
- •The subject is diagnosed with a severe infection (septicemia).
- •Principal investigator determines the subject's condition would prevent the subject from undergoing the study procedure or cannot support a vascular bypass graft.
- •The subject with a stent previously implanted into the target vessel.
- •Subject has disease in both legs where both limbs meet the inclusion criteria and it is planned to treat both limbs within 30 days.
- •Pregnant, possibly pregnant and/or nursing female subjects are excluded, as are female subjects who are willing to have a baby during the trial.
- •The subject is participating in an investigational drug or another investigational device study.
- •Subject has a large amount of blood clot next to the study lesion.
研究组 & 干预措施
MD-12-001 Stent Arm
Experimental
This study includes a single arm, the MD-12-001 Stent Arm.
干预措施: MD-12-001 Stent (Device)
结局指标
主要结局
The proportion of subjects who are free of target limb failure at 12-months post study procedure.
时间窗: 12-months post study procedure
次要结局
- The proportion of subjects with primary target lesion patency.(30-days, 6-, 12-, 24-, and 36-months post study procedure)
- The proportion of subjects with secondary target vessel/lesion patency.(30-days, 6-, 12-, 24-, and 36-months post study procedure)
- Proportion of subjects who achieve acute procedural success.(Perioperative period (period during study procedure))
- Rutherford category assessment.(Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure)
- Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event.(through 60-months post study procedure)
- The proportion of subjects who are free of target limb failure.(30-days, 6-, 24-, and 36-months post study procedure)
- Ankle-brachial index measurements.(Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure)
- Quality of Life (SF-36) Questionnaire(Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure)
- Proportion of Subjects who experience Major Adverse Events.(30-days post procedure)
- The proportion of subjects who undergo target vessel/lesion revascularization (restoration of blood flow)(12-, 24-, 36-, 48-, and 60-months post study procedure)
- Proportion of subjects without stent fracture(30-days, 6-, 12-, 24, and 36-months post study procedure)
研究者
研究点 (12)
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