NCT04664140: AQVA

QFR-based Virtual PCI Versus Angio-guided PCI

Completed NA Last updated 10 May 2023

What this trial tests

NA trial testing QFR-based virtual PCI in Percutaneous Coronary Intervention in 300 participants. Completed in 9 May 2023.

Timeline

20 February 2021

Primary endpoint
27 December 2021

9 May 2023

Quick facts

Lead sponsor	University Hospital of Ferrara
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	300
Start date	20 February 2021
Primary completion	27 December 2021
Estimated completion	9 May 2023
Sites	3 locations across Italy

Drugs / interventions tested

• QFR-based virtual PCI
• angiography-based PCI

Conditions studied

• Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →
• Coronary Physiology — all drugs for Coronary Physiology →

Sponsor

University Hospital of Ferrara

Who can join

18 and older, any sex, with Percutaneous Coronary Intervention or Coronary Physiology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A significant portion of patients continue to experience both adverse events and symptoms after angiographically successful PCI. Beyond different underlying mechanisms non-related to epicardial disease (vasospasm, microcirculatory dysfunction), several recent studies have shown that in at least 15-20% of PCIs, a prognostically meaningful ischemia, detected with different coronary physiology tools, is present at the end of a successful angiography-guided PCI. In addition, physiology is able to discriminate the underlying reason causing the suboptimal functional result, namely: i) in-stent drop; ii) focal drop outside stent; iii) diffuse disease.

However, the use of post-PCI physiology is still very low, even when it is utilized pre-PCI to set the indication for stenting. Lack of dedicated randomized clinical trials and procedural lengthening and increase in side effects are at the basis of this underutilization.

In addition, the ideal tool should allow to plan the intervention in advance rather than to assess the results afterwards. To this hand, QFR is particularly appealing, among available physiology tools, because it does not need wire or adenosine and allows: i) identification of disease mechanism; ii) co-registration with angiography; iii) pre-PCI planning with residual vessel QFR value according to a pre-specified treatment.

Taken all this characteristics together, QFR is the ideal technology for virtual PCI.

The hypothesis of the present investigation is that a procedural planning based on QFR (virtual PCI) is able to reduce the rate of patients with post-PCI suboptimal functional result, that has been found to correlate with prognosis in our earlier study, if compared to the traditional angio-guided PCI.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. QFR-Based Virtual PCI or Conventional Angiography to Guide PCI: The AQVA Trial.
   Biscaglia S, Verardi FM, Tebaldi M, Guiducci V, et al · · 2023 · cited 37× · PMID 36898939 · DOI 10.1016/j.jcin.2022.10.054
2. Practical Application of Coronary Physiologic Assessment: Asia-Pacific Expert Consensus Document: Part 1.
   Koo BK, Lee JM, Hwang D, Park S, et al · · 2023 · cited 15× · PMID 38095005 · DOI 10.1016/j.jacasi.2023.07.003
3. Physiology-Based Revascularization: A New Approach to Plan and Optimize Percutaneous Coronary Intervention.
   Lee JM, Lee SH, Shin D, Choi KH, et al · · 2021 · cited 13× · PMID 36338358 · DOI 10.1016/j.jacasi.2021.03.002
4. Coronary angiography: a review of the state of the art and the evolution of angiography in cardio therapeutics.
   Gurav A, Revaiah PC, Tsai TY, Miyashita K, et al · · 2024 · cited 11× · PMID 39654943 · DOI 10.3389/fcvm.2024.1468888
5. Additional Value of Optical Coherence Tomography-Derived Virtual Flow Reserve for Percutaneous Coronary Intervention Guidance.
   Marrone A, Erriquez A, Verardi FM, Colaiori I, et al · · 2025 · cited 1× · PMID 40988408 · DOI 10.1002/ccd.70207