DRKS00028994招募中未知
Coronary CT Angiography for Guiding Percutaneous Coronary Artery Intervention: a Prospective Randomised Study - CT-PCI TRIA
niversitätsklinikum Erlangen Medizinische Klinik 20 个研究点目标入组 240 人开始时间: 2022年5月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years(—)
- 性别
- All
入选标准
- •1.Subjects must be at least 18 years of age.
- •2.Available coronary CT angiography data set
- •3.Obstructive coronary artery disease with at least one lesion causing > 50% stenosis in a coronary segment planned for percutaneous revascularisation according to clinical decision making.
- •4.Evidence of myocardial ischemia e.g. stable angina, silent ischemia, unstable angina suitable for elective PCI.
- •5.Good CT image quality with absence of artefacts in the affected coronary segment
- •6.No more than 2 target lesions requiring PCI are present in any single vessel, and no more than 2 target vessels are allowed. (PCI to non-target vessels are allowed after 48 hours of index PCI).
- •7.The patient signing a written informed consent.
排除标准
- •1. Age >85 years
- •2. Target lesion location in a previously revascularized segment (stents or coronary artery bypass grafting)
- •3. Left main coronary artery stenosis
- •4. Patients with status post complicated PCI
- •5. Cardiogenic shock or hemodynamic instability
- •6. Creatinine clearance < 30 ml/l/min/1.73 m² as calculated by MDRD formula and not on dialysis.
- •7. Left ventricular ejection fraction < 30%
- •8. Planned cardiac or non-cardiac surgery within 24 months after index procedure
- •9. Prior PCI within the target vessel(s) within 12 months.
- •10. Any prior PCI in a non-target vessel within 24 hours before study or within 30 days if unsuccessful or complicated.
- •11. Planned use of a stent < 2.5 mm in diameter
- •12. Ostial left main stenosis or ostial RCA stenosis
- •13. Patients with chronic renal insufficiency with GFR < 30 ml/min/1.73 m²
- •14. Patients actively participating in another study without completion of the primary endpoint or follow-up period.
研究者
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