NL-OMON32020招募中不适用
Prospective, Non-randomized, Multicentre, Observational Registry To confirm the performance of Misago Peripheral Self-Expanding Stent System for the Treatment of Occluded or Stenotic Superficial Femoral or Popliteal Arteries. - Misago-2 registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Terumo
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with documented symptomatic occlusion and/or >70%
- •stenosis of SFA or popliteal artery in one or both legs;1. Patients with symptomatic one or two legs ischemia, requiring
- •treatment of SFA or popliteal artery (2 or more by Rutherford
- •classification)
- •2. Single lesions per leg with recoiling/dissection/restenosis after
- •balloon angioplasty or de novo lesions with stenosis or occlusion,
- •which can be covered by maximum two stents
- •3. Target vessel reference diameter >=4mm and <=6mm (by visual
- •4. Target lesion length should consider that maximum two Misago
- •stents can be implanted per lesion with recommended overlap 2
- •5. At least one patent (less than 50% stenosis) tibioperoneal run-off
- •vessel confirmed by baseline angiography
- •6. Patient is suitable candidate for femoral-popliteal artery bypass
排除标准
- •Patient with any of the following should be excluded:
- •1. Pregnancy
- •2. Previous bypass surgery or stenting in the target vessel
- •3. Scheduled staged procedure of multiple lesions within the
- •ipsilateral iliac or popliteal arteries within 30 days after index
- •4. Co-existing aneurismal disease of the abdominal aorta, iliac or
- •popliteal arteries
- •5. Acute thrombophlebitis or deep venous thrombosis
- •6. Hemodynamic instability
- •7. Untreated inflow disease of the ipsilateral pelvic arteries (more
- •than 50 percent stenosis or occlusion),
- •8. Significant gastrointestinal bleeding or any coagulopathy that
- •would contraindicate the use of anti-platelet therapy
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