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临床试验/NCT05674630
NCT05674630招募中4 期

TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons

Cardiocentro Ticino2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年2月21日最近更新:
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适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
130
试验地点
2
主要终点
Absolute change of FFR values (ΔFFR)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions.

Participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.

详细描述

Patients at coronary angiography who are deemed suitable for PCI are assessed for eligibility. Patients fulfilling all inclusion and no exclusion criteria can be consented for trial participation. After successful lesion preparation, defined as residual stenosis less than 30%, TIMI flow 3 and no major (type C) dissection of target lesion, consented patients will be randomized in a 1:1 ratio to a drug eluting balloon(DEB)-based or standard drug eluting stent(DES)-based strategy and further randomized in a 1:1 fashion, stratified based on DEB vs DES, to undergo invasive follow-up at 6 (±30 days) or 12 (±30 days) months.

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 (Outcomes Assessor)

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

  • •Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI
  • •At least one significant de-novo coronary lesion (defined as diameter stenosis > 50% on angiography, with flow limiting features, confirmed with FFR ≤0.80 or iFR ≤0.89 and intended implantation of a long (≥30 mm) DES based on IVUS findings
  • •Written informed consent

排除标准

  • •Patients referred to the index procedure for an acute coronary syndrome
  • •Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery
  • •Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment
  • •Spontaneous coronary artery dissection (SCAD)
  • •Contraindications to adenosine administration (e.g. moderate to severe asthma or chronic obstructive pulmonary disease, heart rate <50 beats/min and systolic blood pressure <90 mmHg)
  • •Known pregnancy or breast-feeding patients
  • •Life expectancy <1 year due to other severe non-cardiac disease
  • •Legally incompetent to provide informed consent
  • •Participation in another clinical study with an investigational product

结局指标

主要结局

Absolute change of FFR values (ΔFFR)

时间窗: At 6(±30days) or 12(±30 days) months after the index PCI

Absolute change of fractional flow reserve (FFR) values (ΔFFR) measured at the final assessment immediately after the index PCI and invasive follow-up at 6(±30days) or 12(±30 days) months

次要结局

  • Lumen volume (LV, mm^3)(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Plaque burden (VV-LV)(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Late lumen loss (LLL)(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Acute gain(pre procedure and immediately after the procedure)
  • QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Vessel volume (VV, mm^3)(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Target lesion revascularization (TLR) defined as urgent and non-urgent(5 years after the index PCI)
  • Any myocardial infarction(5 years after the index PCI)
  • QFR parameters before and after intervention and at follow-up angiography(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography.(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • FFR parameters before and after intervention and at follow-up angiography(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Minimal lumen diameter (MLD, mm)(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization(5 years after the index PCI)
  • The individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)(5 years after the index PCI)
  • Definite or probable stent thrombosis(5 years after the index PCI)
  • Minimal luminal area (MLA, mm^2)(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Maximal diameter stenosis (MaxS, percent)(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Stroke(5 years after the index PCI)
  • Disease progression after index PCI(pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI)
  • Target vessel revascularization (TVR), defined as urgent and non-urgent(5 years after the index PCI)

研究者

发起方
Cardiocentro Ticino
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Valgimigli

Coordinating Principal Investigator

Cardiocentro Ticino

研究点 (2)

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