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临床试验/NCT05406284
NCT05406284
招募中
不适用

A Novel Coronary Bifurcation Stenting Technique With Minimal Protrusion: Double Kissing Nano-Culotte Stenting

Istanbul Mehmet Akif Ersoy Educational and Training Hospital1 个研究点 分布在 1 个国家目标入组 12 人2024年7月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Coronary Artery Disease
发起方
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
入组人数
12
试验地点
1
主要终点
MACE (major adverse cardiovascular events)
状态
招募中
最后更新
上个月

概览

简要总结

True coronary bifurcation lesions are still great of interest due to their complex anatomy, uncertainty of optimal stenting strategy and increased adverse cardiovascular outcomes. Provisional stenting is recommended in patients with non-complex coronary lesions while 2-stent strategies should be considered in complex coronary bifurcation lesions. However, optimal 2-stent strategy is still controversial. Double kissing (DK) crush stenting is the prominent technique in true bifurcation lesion, especially in patients with left main coronary artery disease. DK mini-culotte stenting, increasing use in clinical practice, has become popular over DK crush stenting. It was demonstrated in a bench test that stent malapposition was lower in the DK mini-culotte stenting compared to the DK crush technique. Thus, DK mini-culotte stenting may be preferred over DK crush stenting in complex true coronary bifurcation lesion. On the other hand, it was demonstrated in previous studies, less than minimal protrusion (generally called as nano protrusion) had better clinical outcomes. Kawasaki et al was first demonstrated the minimal (nano) protrusion of culotte stenting technique. Then, Toth et al revealed a novel modified culotte stenting technique named single string culotte. There was no major adverse cardiac events (MACE) in patients underwent single string stenting technique with a median follow-up period of 6±4 months. Unsurprisingly there was no MACE occurred in patients who underwent Szabo 2-stent technique. In the light of foregoing data, the least possible amount of protrusion is known to have the best results. In addition to this, double kissing balloon dilatation with culotte stenting technique seems to have better results than other stenting techniques. In our study, we aimed to evaluate the angiographic and clinical results of a novel DK Nano-Culotte stenting in coronary bifurcation lesion.

注册库
clinicaltrials.gov
开始日期
2024年7月1日
结束日期
2026年12月30日
最后更新
上个月
研究类型
Observational
性别
All

研究者

发起方
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
责任方
Sponsor

入排标准

入选标准

  • Patients with de novo true bifurcation lesion (Medina classification 1,1,1 or 0,1,1 or 1,0,1)
  • The main vessel diameter is least 2.5 mm and the side branch diameter is at least 2.25 mm

排除标准

  • Patients presenting with ST segment elevation myocardial infarction, cardiogenic shock and Killip class III-IV heart failure
  • Patients with a history of coronary artery bypass grafting surgery
  • Patients with a chronic total occlusion in the bifurcation area
  • Lesions with severe calcification that needs additional intervention such as atherectomy
  • Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
  • Patients with hematological disorders, malignancy, end stage renal (GFR\<30 ml/min) and hepatic failure
  • Patients with active bleeding
  • Pregnant women
  • Patients with life-expectancy \< 1 year
  • Patients treated with small open cell stent platforms

结局指标

主要结局

MACE (major adverse cardiovascular events)

时间窗: 6 months

target vessel revascularization, myocardial infarction or cardiac death

次要结局

  • MACCE (major adverse cerebral and cardiovascular events)(6, 12 months)
  • target lesion failure(6, 12 months)

研究点 (1)

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