NCT06484647招募中不适用
Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation: Insights From TREX Registry
San Luigi Gonzaga Hospital1 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2024年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
详细描述
- According to DEFINITION criteria, PCI of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularization (TVR) compared to Provisional Stenting
- The Double-Kissing Crush stenting (DK-Crush) has been tested with the Culotte and the Classic Crush techniques in the unprotected left main disease (ULMD) and in no-ULMD setting, respectively, showing better clinical outcomes.
- However, due to its technical complexity and simultaneous improvement of the Classic Crush technique evolving in the External Minicrush, it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation
- The DK-Crush technique has never been tested with the External Minicrush, leaving the operators to choose one or the other according to their experience and preferences.
- The T-stenting And Minimal Protrusion (TAP) is a two-stent technique described to treat coronary bifurcation after provisional treating. Compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting.
- Nowadays, no studies compare theTAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
- The issue's importance is highlighted by higher rates of stent thrombosis (ST) and in-stent restenosis (ISR) of the two stent techniques compared to Provisional Stenting in treating coronary bifurcation8.
- Consequently, investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-PCI TLR.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years of age
- •Patients with an indication for PCI, including chronic coronary syndrome and acute coronary syndromes (STEMI, NSTEMI, unstable angina)
- •Patients with at least one true coronary bifurcation according to the Medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1
排除标准
- •Patients who do not want or cannot sign the informed consent for the procedure.
- •Patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe.
- •Patients with a life expectancy of <1 year.
- •Patients with planned major surgery require prolonged discontinuation of antiplatelet therapy.
- •Pregnant women.
- •Patients who cannot take antiplatelet therapy for any reason.
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 5-years
a composite of cardiac death and target vessel-related myocardial infarction (TV-MI), including Q wave, non-Q wave myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
次要结局
- Target Vessel MI (TVMI)(5-years)
- Intrastent-restenosis (ISR)(5-years)
- Stent thrombosis (ST)(5-years)
研究者
Enrico Cerrato
Medical Doctor, MD
San Luigi Gonzaga Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary BifurcationCoronary Artery DiseaseCoronary StenosisCoronary DiseaseNCT05782738San Luigi Gonzaga Hospital361
尚未招募
3 期
Comparison of 2 methods for treatment of missing gums in between teeth.CTRI/2024/02/063384Bindu DR
已完成
早期 1 期
Comparative study of the effect of TAP (Transverse Abdominis Plane) block and anesthesia infiltration site on postoperative pain in patients with unilateral inguinal hernia repair surgeryIRCT20191103045320N2Kashan University of Medical Sciences63
已完成
不适用
Comparison of Radial and Ulnar Artery Intervention in Patients With ST Elevated Myocardial InfarctionST Elevated Myocardial InfarctionNCT04183140Sakarya University200
已完成
不适用
T-provisional Stenting vs Mini-Crush in Chronic Total Occlusions (CTO)Ischemic Heart DiseaseCoronary AtherosclerosisCoronary Artery StenosisCoronary Artery DiseaseNCT02708329Meshalkin Research Institute of Pathology of Circulation146