JPRN-UMIN000037805已完成3 期
ovel DCB for Coronary Artery Disease Trial - Novel DCB Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Clinical Exclusion Criteria 1. Subject has had an AMI within 72 hours prior to the procedure. 2. Subject has severe LVEF <30%. 3. Subject has a platelet count <100,000 cells/mm^3 or >700,000 cells/mm^3. 4. Subject has a WBC count < 3,000 cells/mm^3. 5. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. 6. Subject has had a history of CVA or TIA within the past 6 months. 7. Subject has an active peptic ulcer or active GI bleeding. 8. Target vessel has been treated with Paclitaxel Eluting Stent or Balloon prior to the index procedure. 9. Target vessel has been treated with any type of PCI within 6 months prior to the procedure. 10. Target vessel requires the use of adjunctive primary treatment modalities immediately prior to investigational device's treatment. 11. Non-target vessel has been treated with any type of PCI within 24 hours prior to the procedure. Angiographic Exclusion Criteria 1. Target lesion meets any of the following criteria: - Left main location. - Located within 5 mm of the origin of the LAD or LCX by visual estimate. - >50% stenosis of an additional lesion proximal or distal to the target lesion. - Located within a saphenous vein graft or an arterial graft. - Will be accessed via a saphenous vein graft or an arterial graft. - Involves a complex bifurcation. - TIMI flow 0 prior to wire crossing. - Excessive tortuosity proximal to or within the lesion. - Extreme angulation proximal to or within the lesion. - Target lesion and/or target vessel adjacent to the target lesion presents with dissection or aneurysm by visual estimate. - Restenosis from previous intervention (SV). - In-stent restenosis due to stent fracture or recoil (ISR). 2. Non-target lesion to be treated during the procedure meets any of the following criteria: - Located in the target vessel (ISR). - Located within a bypass graft - Left main location. - Chronic total occlusion. - Involves a complex bifurcation.
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