跳至主要内容
临床试验/NCT05658952
NCT05658952已完成不适用

Angio- or Microcatheter- Quantified FFR Virtual PCI Versus Angio-guided PCI in the Achievement of an Optimal Post-PCI FFR

University Hospital of Ferrara3 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
305
试验地点
3
主要终点
Post-PCI Fractional Flow Reserve (FFR)

研究概览

简要总结

Angiography-derived Fractional Flow Reserve (FFR) Virtual Percutaneous Coronary Intervention (PCI) plan is superior to conventional angiography-guided PCI in obtaining a good final physiology result, which is, in turn, associated with better prognosis. This has been demonstrated in a population with a relatively low lesion complexity.

Therefore, whether angiography-based FFR virtual PCI could guarantee the same results in some complex anatomical settings (tortuous or calcific vessels, tandem or bifurcation lesions) is not known, also given the inherent limitations of the 3Dimensional (3D)-reconstruction.

The ability of invasive FFR to achieve the same result if compared to angiography-guided PCI has been questioned by recent studies. Recent technological developments, namely the design of pressure wire microcatheters may allow an easier handling of the procedural planning and guidance.

The rationale of the AQVA II study is to test whether a longitudinal FFR-based virtual PCI either angio- or microcatheter- derived is able to improve the post-PCI physiology value if compared to angio-guided PCI in complex and high-risk indicated procedures (CHIP).

详细描述

Despite the accumulating evidence regarding functional indices utility in setting the indication to and planning percutaneous coronary interventions (PCI), the use of functional assessment in clinical practice is still limited. This is especially true in the post-PCI setting, probably due to lack of evidence and/or specific guidelines/recommendations on how to "react" to a suboptimal post-PCI functional result.

New indices and tools have been developed in an effort to overcome the barriers to a widespread adoption of functional assessment.

All these technological advances brought physiology to a new level transitioning from a binary interpretation of the functional evaluation - positive or negative - to a longitudinal analysis of the whole vessel. The reconstruction of a "physiological map" enables to quantify the physiological impact of each coronary segment/lesion and to identify the mechanisms underlying the suboptimal physiology result at the vessel level. This ability can be translated in simple manoeuvres able to improve the final physiology results and then the patient's prognosis.

The inherent limit of post-PCI physiology is to add measurement and consequent actions after the end of the procedure and not upfront. In addition, it is associated with the increase in procedural time and costs. Thus, a broad application of post-PCI physiology, although clinically meaningful, is difficult.

On the contrary, the systematic application of angiography-derived FFR before stenting to simulate PCI results according to different treatment strategies (virtual PCI) would be an interesting alternative to achieve a fully physiology-guided and optimized procedure. The powerful technological development lays in the possibility to simulate the treatment of one or more lesion, in order to estimate the residual functional value post-PCI: the so-called virtual PCI. These tools are particularly effective in multi-vessel disease patients and in tandem serial stenosis, allowing to individualize the treatment of those lesions related to poor clinical outcomes and avoiding superfluous coronary interventions.

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)

盲法说明

The Independent Clinical Event Committee will perform the blinded adjudication of the events. The Independent Angiography and Physiology Core-lab will perform the primary endpoint analysis

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Indication to PCI for either acute or chronic coronary syndrome
  • Signed informed consent
  • At least one of the following CHIP lesion characteristic:
  • Long lesion (>28 mm);
  • Tandem lesions;
  • Severe calcifications;
  • Severe tortuosity;
  • True bifurcation lesions: involving a significant (> 50%) diameter stenosis both in the main vessel and side branch (i.e. MEDINA 1,1,1; 1,0,1; or 0,1,1) and with a relevant side branch, namely ≥2.00 mm;
  • In-stent restenosis (ISR).
  • Left main stem disease.

排除标准

  • Planned surgical revascularization
  • Prior Coronary Artery Bypass Graft (CABG) Surgery
  • Culprit lesion of STEMI or NSTEMI
  • Revascularization of a chronic total occlusion
  • Non-cardiovascular co-morbidity reducing life expectancy to < 1 year
  • Any factor precluding 1-year follow-up

结局指标

主要结局

Post-PCI Fractional Flow Reserve (FFR)

时间窗: at the end of the procedure (at the moment of the last angiography)

At the end of the procedure in all patient a blinded invasive post-PCI FFR will be obtained

次要结局

  • Post-PCI Distal Pressure (Pd) / Aortic Pressure (Pa)(at the end of the procedure (at the moment of the last angiography))
  • VOCE(1 year)

研究者

发起方
University Hospital of Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluca Campo

Study Chair

University Hospital of Ferrara

研究点 (3)

Loading locations...

相似试验