NL-OMON37935招募中不适用
A Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Tryton Side Branch Stent* used in Conjunction with a Drug-Eluting Stent Compared to Side Branch Balloon Angioplasty in Conjunction with a Drug-Eluting Stent in the Treatment of de novo Bifurcation Lesions Involving the Main Branch and Side Branch within the Native Coronary Circulation - Tryton Side Branch Stent* Compared to Side Branch Balloon Angioplasty
Tryton Medical Corporate Headquarters0 个研究点目标入组 105 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
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
- •Patients must meet ALL of the following criteria:
- •General Inclusion Criteria
- •1. The patient must be >=18 and <= 90 years of age;
- •2. Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or have objective evidence of myocardial ischemia);
- •3. Acceptable candidate for CABG;
- •4. The intent to treat the side branch of the target bifurcation based on angiographic evaluation;
- •5. The patient is willing to comply with specified follow-up evaluations;
- •6. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB).
- •7. Planned use of one of the following approved and commercially available drug-eluting stents for subject*s index procedure: CYPHER®, RESOLUTE Family of products (ENDEAVOR®
- •RESOLUTE or RESOLUTE INTEGRITY), PROMUS®, PROMUS ELEMENT Family of products (PROMUS® ELEMENT or PROMUS ELEMENT PLUS), XIENCE* V, or the XIENCE
- •PRIME Family of products (XIENCE PRIME, XIENCE Xpedition or XIENCE PRO)
- •Angiographic Inclusion Criteria
- •8. a)Single de novo lesion in a bifurcation involving both the main branch and the side branch with
- •b) The bifurcation: main branch and side branch with a visual diameter stenosis >= 50% (Medina classification 1.1.1; 0.1.1; 1.0.1 by visual assessment);
- •9. Target lesion located in a native coronary artery;
- •10. a)Bifurcation lesion main branch reference vessel diameter must be >=2.5 mm to <= 4.0 mm
- •b) Side branch reference vessel diameter must be >=2.5 mm to <= 3.5 mm by visual estimate;
- •11. a) Bifurcation lesion main branch lesion length <= 28 mm
- •b) Side branch lesion length <= 5.0 mm (the ability to be treated with a single stent for both main and side branch);
- •12. Target lesion >=50% and <100% stenosed by visual estimate in both the main branch and side branch;
- •Refer to Protocol 1.9.5 for full list of Inclusion Criteria
排除标准
- •Patients will be excluded if ANY of the following conditions apply:
- •General Exclusion Criteria
- •1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
- •2. Patient has had a known diagnosis of STEMI acute myocardial infarction (AMI) within 72 hours preceding the index procedure or >72 hours preceding the index procedure and CK and CK-MB have not returned to within normal limits at the time of procedure;
- •3. Patients with non-STEMI within 7 days prior to index procedure with continued CK-MB elevation;
- •4. Patients with non-target lesion PCI within 7 days prior to index procedure with continued CK-MB elevation;
- •Angiographic Exclusion Criteria
- •5. Left main coronary artery disease (protected and unprotected)
- •6. Trifurcation lesion;
- •7. Totally occluded target vessel (TIMI flow 0 or 1);
- •8. Severely calcified target lesion(s);
- •9. Highly calcified target lesion(s) requiring rotational atherectomy;
- •10. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
- •11. Angiographic evidence of thrombus in the target lesion(s);
- •Refer to Protocol for full list of Exclusion Criteria.
研究者
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