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临床试验/NCT03111940
NCT03111940已完成不适用

The Oxford Optimisation of PCI Study (OXOPT-PCI Study)

Oxford University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Final Fractional Flow Reserve (FFR) After Intracoronary Stenting

研究概览

简要总结

The OxOPT-PCI study addresses patients with coronary artery disease who are referred to the John Radcliffe Hospital because of the need for treatment with an intra-coronary stent (metal scaffold) for clinical reasons. Although, this has become a highly standardised procedure it is still challenging for the clinician to assess the final success of this procedure at the end of intervention with conventional methods. This shortcoming can potentially translate into a worse clinical outcome for approximately 10 percent of all patients treated with an intra-coronary stent for this type of disease.

This study (OxOPT-PCI) investigates if the use of blood flow measurements (namely measurement of fractional flow reserve (FFR)) and intravascular imaging (namely optical coherence tomography (OCT)) after the implantation of a stent can improve the treatment result for these patients. Both, FFR and OCT are being used already in daily clinical routing but their usefulness especially in combination is not clear. In order to standardise the optimisation procedure we developed a specific algorithm to make sure that all patients receive the same optimisation measures based on the assessment of FFR and OCT.

The benefit of this specific optimisation algorithm will be assessed by measuring 1) indices of coronary blood flow, 2) intravascular imaging at the end of the procedure, and 3) by contacting the patients 12 months after stenting to verify the clinical mid-term success.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •participant is willing and able to give informed consent for participation in the study
  • •angiogram shows haemodynamically relevant lesion suitable for PCI and suitable for the use of intravascular imaging (OCT)

排除标准

  • •patients in whom safety or clinical concerns preclude participation
  • •ST-segment elevation myocardial infarction
  • •presentation with cardiogenic shock
  • •revascularization by mean of balloon angioplasty without stenting
  • •contraindications to adenosine

研究组 & 干预措施

PCI optimisation

Experimental

Post PCI FFR below 0.9

干预措施: Optimisation of the result of intracoronary stenting according to specific algorithm (Procedure)

No PCI optimisation

No Intervention

Post PCI FFR 0.9 or higher

结局指标

主要结局

Final Fractional Flow Reserve (FFR) After Intracoronary Stenting

时间窗: Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1A

After administration of intracoronary nitrates, FFR was measured under maximal hyperaemia, using intravenous adenosine (140 mg kg-1 min-1) as the ratio between distal coronary pressure (Pd) and aortic pressure (Pa)

次要结局

  • Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT(During PCI procedure, OCT typically adds 5 minutes to the procedure)
  • Number of Participants With Stent Malapposition Assessed by OCT(During PCI procedure, OCT typically adds 5 minutes to the procedure)
  • Number of Participants With Stent Under-expansion Assessed by OCT(During PCI procedure, OCT typically adds 5 minutes to the procedure)
  • Number of Participants With Stent-edge Dissection Assessed by OCT(During PCI procedure, OCT typically adds 5 minutes to the procedure)
  • Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT(During PCI procedure, OCT typically adds 5 minutes to the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Banning

Professor

Oxford University Hospitals NHS Trust

研究点 (1)

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