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临床试验/NCT04917432
NCT04917432尚未招募不适用

Early and Midterm Outcomes of Intravascular Ultrasound (IVUS) Versus Non-IVUS Guidance in Complex Coronary Chronic Total Occlusion (CTO) Revascularization.

Assiut University0 个研究点目标入组 70 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
procedural success

研究概览

简要总结

Various CTO percutaneous coronary intervention (PCI) studies defined CTO as as a substantial atherosclerotic blockage with >3 months duration of TIMI (Thrombolysis in Myocardial Infarction) 0 flow other than via collaterals. Following CTO-PCI, various well-established therapeutic benefits have been extensively acknowledged, such as improved angina frequency score and quality of life score from the Seattle Angina Questionnaire (SAQ). Patients are currently referred for CTO PCI to relieve symptoms, reduce ischemia load, or pursue full revascularization to improve left ventricular ejection fraction (LVEF) CTO-PCI is one of the most difficult procedures in interventional cardiology today. Although IVUS has been demonstrated to improve long-term results during CTO PCI when used for stent optimization, its impact on crossing has received little research. IVUS imaging can aid in the resolution of proximal cap ambiguity by determining the position of the main branch and determining the position of the guidewire during CTO crossing efforts both antegrade and retrograde. For the reverse controlled antegrade and retrograde tracking and dissection (reverse CART) procedure, IVUS can help establish the best balloon size. In addition, imaging guidance can help in balloon and stent sizing, as well as stent expansion and strut apposition.

The function of IVUS in CTO PCI has been a source of contention among the four major CTO schools hybrid algorithms. The importance of IVUS-guided entry in overcoming proximal cap uncertainty was underlined in the Asia Pacific algorithm. Furthermore, IVUS-guided wiring, limited subintimal tracking and re-entry are incorporated in the algorithm as alternatives, but only as last resorts. After performing dual coronary injections, the North American hybrid method evaluates four angiographic characteristics, the first of which is a clear understanding of the proximal cap placement utilising angiography or IVUS. They also explain how IVUS guidance can help with reverse CART by allowing for the proper balloon size selection. When proximal cap ambiguity is found in the Euro CTO club algorithm, antegrade procedures such as IVUS-guided puncture and scratch and go technique are performed. When using a primary retrograde approach, the probability of antegrade passing with IVUS guidance and parallel wiring, as well as the advantage of a shorter guide wire crossing time when employing an antegrade route alone, must be incorporated in the Japanese algorithm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • All coronary CTO patients in whom coronary anatomy is defined by coronary CT and/or Coronary angiography provided that:- CTO defined as heavy atherosclerotic occlusion with TIMI (Thrombolysis in Myocardial Infarction) 0 flow other than via collaterals for >3 months and they are symptomatic despite optimal medical therapy and/or positive high risk stress modality.

排除标准

  • Acute coronary syndrome within 3 months.
  • Patients with renal insufficiency (eGFR < 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on regular dialysis).
  • Patients with expected post CTO-PCI procedure SYNTAX >
  • Hemodynamically unstable patients.

结局指标

主要结局

procedural success

时间窗: within three days

technical success without in-hospital MACE (death, myocardial infarction, need for urgent PCI or CABG and stroke).

Technical success

时间窗: Within three to six hours

Restoration of antegrade flow with residual stenosis below 30% assessed using IVUS by measuring the minimal lumenal area in mm2

major adverse cardiovascular events (MACE)

时间窗: within six months

death, myocardial infarction, repeat target vessel revascularization with either PCI or coronary artery bypass graft surgery and stroke

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Saber Abdelaal Qayed

Assistant lecturer

Assiut University

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