Use of Physiology to Evaluate Procedural Result After PCI CTO
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Isala
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR.
研究概览
简要总结
ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for percutaneous coronary intervention (PCI) of chronic total occluded (CTO) coronary artery.
The main objective of the study is to assess the predictive value of post-PCI resting full-cycle ratio (RFR) and fractional flow reserve (FFR) with regard to Fractional flow reserve (SSR) in CTO patients.
详细描述
ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for PCI CTO.
The main objective of the study is to evaluate both the value of post-PCI RFR and post-PCI FFR for detecting suboptimal stent result (SSR).
After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR)) of the CTO vessel will be performed. Additional OCT will be performed directly or during a staged procedure within 4 ± 2 weeks when indicated (i.e. high contrast use, procedural duration, major dissection or other safety reasons according to the operator).
When intra-coronary physiologic assessment or OCT is not possible at all, the patients will not be included in the study.
When the operator decides to optimize the stent result (post-dilation or additional stenting), based on the OCT and/or physiology, post-PCI RFR and FFR should be repeated. For patients undergoing a clinically indicated FFR of a remaining intermediate stenosis (angiographically 30-90%) in a non-CTO vessel or major side branch of the CTO vessel within 4 weeks after the index procedure, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) will be repeated in the CTO vessel for exploratory objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age 18 years and older.
- •Angiographically successful PCI CTO without any remaining lesion at least 30% proximal to the stented segment.
- •Possibility to perform physiologic measurements and OCT of sufficient quality.
- •Patients willing and capable to provide written informed consent.
排除标准
- •1) Contra-indication for adenosine.
研究组 & 干预措施
Post-PCI intra-coronary physiological and OCT measurements
After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) and OCT of the CTO vessel will be performed directly. OCT may als be performed during a staged procedure within 4 ± 2 weeks after the index procedure when clinically indicated.
干预措施: post-PCI Pd/Pa (Diagnostic Test)
结局指标
主要结局
The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR.
时间窗: Index procedure (or staged procedure if indicated).
The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR.
次要结局
- Seattle Angina Questionnaire (SAQ) score at follow-up(4± 2 weeks)
- New York Heart Association (NYHA) classification at follow-up(4± 2 weeks)
- Canadian Cardiovascular Society (CCS) classification at follow-up(4± 2 weeks)
- Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at follow-up(4± 2 weeks)
- The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients.(Index procedure (or staged procedure if indicated).)
- The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) with regard to SSR following angiographically satisfactory CTO PCI.(Index procedure (or staged procedure if indicated).)
- The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score), NYHA and CCS classification and MACE at follow-up(Index procedure (or staged procedure if indicated) until 4± 2 weeks follow-up)
- The impact on physician-decision making based on OCT and physiology findings(Index procedure (or staged procedure if indicated).)
研究者
Maarten van Leeuwen
Principial Investigator Isala
Isala