跳至主要内容
临床试验/DRKS00028994
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

发起方
niversitätsklinikum Erlangen Medizinische Klinik 2

相似试验