Impact of Real-time Angiographic Co-registered OCT on PCI Results - the Randomized OPTICO-integration II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Incidence of a combined endpoint based on "major edge dissections" (I) AND/OR "geographical mismatch" (II) [%]
研究概览
简要总结
Intracoronary optical coherence tomography (OCT) imaging allows for high-resolution characterization of coronary lesions. Difficulties in matching cross-sectional OCT-images with angiographic lesion localization, however, may limit its clinical utilization. The investigators sought to prospectively assess the impact of a novel system of real-time OCT-coregistration with angiography (ACR) compared to OCT alone and to the clinical standard proceeding (angiographic guided-PCI) all used for coronary lesion evaluation before percutaneous coronary interventions (PCI). The investigators hypothesize that the use of ACR will lead to less incidence of insufficient covered coronary lesions (geographical mismatch) and/or a less rate of edge dissections after PCI (combined primary study endpoint)
详细描述
In this randomized blinded pilot-study the effect of pre-PCI planning by angiographic-co-registered OCT (ACR) compared to OCT or angiographic evaluation alone with respect to the entire result after PCI will be investigated. A special focus (primary endpoint) will be on the incidence of geographical mismatch (GM) and/or major edge dissections. Eligible patients will be randomized in three groups.
Group 1 Pre-PCI-OCT: Patients underwent OCT-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on OCT findings.
Group 2: Pre-PCI-ACR: Patients underwent ACR-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on ACR-findings.
Group 3:OCT-Blinded/Angiographic guided PCI: Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators only based on angiographic lesion evaluation (standard care).
For outcome analysis all study groups underwent post-PCI-OCT imaging as soon as investigators assume angiographic justiciable PCI-results (TIMI III, no residual stenosis > 50%; no angiographic definable or suspicious edge dissections, angiographic acceptable stent expansion without evidence for malapposition). OCT imaging analysis will be performed within a OCT core-lab by two investigators blinded for the randomization group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with indication for coronary angiography for angina (stable or unstable), silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive invasive or non-invasive test must be present), or NSTE-ACS
- •male or non pregnant female patient
- •Signed written informed consent
排除标准
- •Known neoplasia on treatment / without a curative therapeutic approach
- •Presence of one or more co-morbidities which reduces life expectancy to less than 24 months
- •Estimated creatinine clearance <40 ml/min
- •Cardiogenic shock
- •Hemodynamic instability because of arrhythmia
- •Known left ventricular ejection fraction (LVEF) <30%.
- •Therapy requiring psychiatric disorder
- •Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
- •Women who are pregnant or breastfeeding
- •Refusal of study participation
研究组 & 干预措施
Blinded-group
Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators only based on angiographic lesion evaluation (standard care)
干预措施: Angio-PCI (Procedure)
OCT-group
Patients underwent OCT-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on OCT findings
干预措施: OCT-PCI (Procedure)
ACR-group
Patients underwent ACR-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on ACR-findings
干预措施: ACR-PCI (Procedure)
结局指标
主要结局
Incidence of a combined endpoint based on "major edge dissections" (I) AND/OR "geographical mismatch" (II) [%]
时间窗: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Analysis of primary endpoint will be assessed by evaluation of proximal and/or distal stent end. I) Major edge dissection (MED): Major: ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length II) Geographical mismatch (GM): Untreated plaque with a minimal lumen area \<4,5mm2 within 5mm of the reference segment. In the postPCI-OCT analysis it is considered as no geographical mismatch, if: 1. the segment of the lesion is fully covered AND 2. the stent protrudes maximal 5mm beyond the predetermined landing zone. If one of these criteria is not fulfilled, it is considered as geographical mismatch
次要结局
- Incidence of "all edge dissections" (major (I) and minor (II)) [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Acute Luminal Gain of target lesion [mm](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Total stent length [mm](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Total number of stents(Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Incidence of "major edge dissections" [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Incidence of "malapposition" [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Minimal Stent Area (MSA) of target lesion [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Total fluoroscopy time [min](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Total contrast volume [ml](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Complications associated with OCT-examination [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Complications during hospitalization [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Stent expansion [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Procedure time [min](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Incidence of "geographical mismatch" [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Inacceptable stent expansion [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Distance between target and actual lesion coverage [mm](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- DOCE within target lesion [%](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Maximal stent diameter [mm](Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
研究者
David Manuel Leistner
PD Dr. med., Principal Investigator
Charite University, Berlin, Germany