CTRI/2011/06/001830招募中4 期
A prospective, Single Blind, Multi-center, Randomized Trial to Compare the TAXUS Element? Coronary Stent System against the XIENCE Prime? Coronary Stent System in the treatment of a Diabetic Patient PopulatiOn in India. - Tuxedo- India
Fortis Escorts Heart institute and Research centre0 个研究点目标入组 1,830 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,830
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
入选标准
- •CI1.Patient must have a diagnosis of diabetes mellitus (Type 1 or Type 2) defined according to the American Diabetes Association as history of one of the followings -
- •1.Two hour plasma glucose more than 200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test
- •2.Random plasma glucose more than 200 mg/dL
- •3. A fasting plasma glucose level more than 126 mg/dL (7.0 mmol/L)
- •4. Elevated HbA1c level more than or equal to 6.5
- •currently undergoing pharmacological treatment
- •5. Patients admitted with ACS NSTEMI and HbA1c more than 7 can be included even if they were not on pharmacological treatment
- •CI2.Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
- •CI3. Patient is eligible for percutaneous coronary intervention (PCI)
- •CI4. Patient has symptomatic coronary artery disease or documented silent ischemia
- •CI5. Patient is willing to comply with all protocol-required follow-up evaluation
- •AI1. Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) more than or equal to 2.25 mm and less than 4.0 mm. Treatment of up to 3 de novo target lesions is allowed with a maximum of two de novo target lesions per epicardial vessel.
- •AI2. Target lesion length must measure less than 34 mm (by visual estimate)
- •AI3. Target lesion must be in a major coronary artery or branch with visually estimated stenosis more than or equal to 50% and less than 100% with Thrombolysis in Myocardial Infarction (TIMI) flow less than 1
- •AI4. If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria.
- •AI5. Non-study percutaneous intervention for lesions in a target vessel (including side branches) is allowed if performed more than or equal to 9 months prior to the index procedure.
- •AI6. Non study percutaneous interventions for lesions in a non target vessel are allowed in the following circumstances:
- •a. Unsuccessful, or complicated bare metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if performed more than or equal to 30 days prior to the index procedure.
- •b. Drug-eluting stent treatment is permitted if performed more than or equal to 90 days prior to index procedure.
- •AI7. Non study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if performed more than 9 months after the index procedure.
排除标准
- •CE1.Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, iron, thienopyridines, aspirin, radiographic contrast medium) that cannot be adequately pre-medicated.
- •CE2.Patient has any other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months
- •CE3. Acute or chronic renal dysfunction (creatinine 2.0 mg/dl or 177 µmol/l)
- •CE 4. Currently participating in another investigational drug or device study
- •AE1.Target lesion meets any of the following criteria:
- •?Left main location including left main ostial location
- •?Located within 2 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate
- •?Located within a saphenous vein graft or an arterial graft or distal to a diseased arterial or saphenous vein graft. Diseased graft defined as irregularity per angiogram and any visually estimated diameter stenosis 20%.
- •?Involves a bifurcation in which the side branch ≥2.0 mm in diameter AND the ostium of the side branch is 50% stenosed by visual estimate.
- •?Involves a side branch requiring pre-dilatation
- •?TIMI flow 0 (total occlusion) prior to guide wire crossing
- •?Excessive tortuosity proximal to or within the lesion
- •?Extreme angulation (≥90o) proximal to or within the lesion
- •?Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
- •?Restenotic from previous intervention
- •?Thrombus, or possible thrombus, present in the target vessel
- •AE2.Patient has an additional clinically significant lesion(s) in the target vessel for which an intervention within 9 months after the index procedure may be required
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