NL-OMON32585已完成4 期
Post market study to evaluate the vascular response to the Sideguard® Coronary Sidebranch Stent in de novo coronary bifurcation lesions using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) Protocol ID: SG3 Revision #1 Date: 09 Sep 09 - Sideguard 3 (SG3) IVUS OCT Trial
Capella Medical devices Ltd.0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- 18 至 99（—）
入选标准
- •1. Above 18 years of age.
- •2. Significant ischemic heart disease (CCS class, Braunwald class B, C and I *II, or documented silent ischemia).
- •3. Treatment of a single bifurcated de novo lesion in a native vessel (Medina type 1,1,1; 1,0,1; 0,1,1).
- •4. Main vessel lesion in a vessel with a reference vessel diameter (RVD) of 2.8 * 4.0mm and 30 mm in length and a sidebranch lesion with a RVD of 2.25 * 3.25mm and 7mm in length (visual estimate) in patients with single or multi vessel disease.
- •5. Acceptable candidate for coronary intervention and coronary bypass surgery.
- •6. The patient has been informed about the trial, agrees to its provisions and provided written informed consent approved by the applicable committee (EC).
- •7. Target lesion must be <100% occluded by visual estimate (minimum TIMI 2 Flow)
排除标准
- •1. Target lesion is a totally occluded main vessel or sidebranch.
- •2. Target lesion has extensive tortuosity or calcification unsuitable for stent delivery and deployment.
- •3. Target lesion bifurcation cannot be clearly visualized by angiography (location of ostium border line and the sidebranch angle).
- •4. Target lesion is located in the left main coronary artery or a RAMUS anatomy.
- •5. Recent myocardial infarction (either STEMI or Non-STEMI < 72 hours prior to planned index procedure).
- •6. Angiographic evidence of occlusive thrombus.
- •7. Ejection fraction < 30%.
- •8 Impaired renal function (serum creatinine > 2.0mg/dl).
- •9 Known allergies to aspirin, clopidogrel or ticlopidine, heparin, nitinol, *limus family of compounds*, or taxane compounds.
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