QFR-based Virtual PCI Versus Angio-guided PCI

NCT04664140 | Completed DMC

• 1 other identifier: 1021/2020/Sper/AOUFe
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Percutaneous Coronary Intervention; Coronary Physiology

Keywords

angio-based FFR; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• post-PCI QFR

  proportion of patients with a final post-PCI QFR result ≥0.90

  end of the procedure

Secondary Outcomes (1)

• vessel-oriented composite endpoint (VOCE)

  1 year

Study Arms (2)

QFR-based virtual PCI

EXPERIMENTAL

Before starting PCI, the operator must acquire QFR angiographic projections after nitroglycerin administration at 15 frames/second. Angiographic projections should be at least 25 apart, aiming for minimal vessel foreshortening and minimal vessel overlap. In agreement with previous studies, operators follow a table of recommended projection angles. Afterwards, online QFR analysis must be performed. The tool "residual vessel QFR" should be used to anticipate the result of stenting (virtual PCI) by placing the proximal (p) and distal (d) marker in order to obtain a post-PCI QFR ≥0.90. then, the operator has to implant one or more stents following the pre-PCI plan and utilizing the QFR and angio to place the stent(s) according to the virtual PCI plan. Post-dilation with non-compliant (NC) balloon is strongly suggested. Blinded QFR projections must be obtained after PCI.

Other: QFR-based virtual PCI

Angiography-based PCI

ACTIVE COMPARATOR

Invasive coronary angiography and PCI are performed following best local practices. Post-dilation with a noncompliant balloon is strongly suggested. Blinded QFR projections must be obtained before and after PCI.

Other: angiography-based PCI

Interventions

QFR-based virtual PCI OTHER

Procedural planning of PCI based on the pullback trace given by the QFR systems in order to obtain an optimized functional result after PCI

Also known as: angio-FFR based virtual PCI

QFR-based virtual PCI

angiography-based PCI OTHER

PCi according to international guidelines, local protocols and practice

Also known as: angio-based PCI

Angiography-based PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication to PCI for either acute or chronic coronary syndrome
• Signed informed consent

You may not qualify if:

• Planned surgical revascularization
• Prior Coronary Artery Bypass Graft (CABG) Surgery
• Culprit lesion of STEMI or NSTEMI
• Clinical or angiographic features limiting QFR computation:
• Left main or ostial right coronary artery
• Atrial fibrillation
• Ongoing ventricular arrhythmias
• Significant and persistent tachycardia
• Revascularization of a chronic total occlusion
• Non-cardiovascular co-morbidity reducing life expectancy to \< 1 year
• Any factor precluding 1-year follow-up

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (3)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

University Hospital Federico II

Napoli, Italy

Location

Azienda Ospedaliera Santa Maria

Reggio Emilia, Italy

Location

Related Publications (6)

• Biscaglia S, Tebaldi M, Brugaletta S, Cerrato E, Erriquez A, Passarini G, Ielasi A, Spitaleri G, Di Girolamo D, Mezzapelle G, Geraci S, Manfrini M, Pavasini R, Barbato E, Campo G. Prognostic Value of QFR Measured Immediately After Successful Stent Implantation: The International Multicenter Prospective HAWKEYE Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2079-2088. doi: 10.1016/j.jcin.2019.06.003. Epub 2019 Sep 25.

  PMID: 31563688 BACKGROUND

• Jeremias A, Davies JE, Maehara A, Matsumura M, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp A, Ali ZA, Mintz G, Patel M, Stone GW. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001. doi: 10.1016/j.jcin.2019.05.054.

  PMID: 31648761 BACKGROUND

• Tebaldi M, Biscaglia S, Fineschi M, Musumeci G, Marchese A, Leone AM, Rossi ML, Stefanini G, Maione A, Menozzi A, Tarantino F, Lodolini V, Gallo F, Barbato E, Tarantini G, Campo G. Evolving Routine Standards in Invasive Hemodynamic Assessment of Coronary Stenosis: The Nationwide Italian SICI-GISE Cross-Sectional ERIS Study. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1482-1491. doi: 10.1016/j.jcin.2018.04.037. Epub 2018 May 23.

  PMID: 29803695 BACKGROUND

• Piroth Z, Toth GG, Tonino PAL, Barbato E, Aghlmandi S, Curzen N, Rioufol G, Pijls NHJ, Fearon WF, Juni P, De Bruyne B. Prognostic Value of Fractional Flow Reserve Measured Immediately After Drug-Eluting Stent Implantation. Circ Cardiovasc Interv. 2017 Aug;10(8):e005233. doi: 10.1161/CIRCINTERVENTIONS.116.005233.

  PMID: 28790165 BACKGROUND

• Marrone A, Erriquez A, Verardi FM, Colaiori I, Cocco M, Caglioni S, Tumscitz C, Penzo C, Marchini F, Meinen J, McNutt J, Buijs JOD, Chiu WC, Versaci F, Campo G, Biscaglia S. Additional Value of Optical Coherence Tomography-Derived Virtual Flow Reserve for Percutaneous Coronary Intervention Guidance. Catheter Cardiovasc Interv. 2025 Dec;106(7):3456-3464. doi: 10.1002/ccd.70207. Epub 2025 Sep 23.

  PMID: 40988408 DERIVED

• Biscaglia S, Verardi FM, Tebaldi M, Guiducci V, Caglioni S, Campana R, Scala A, Marrone A, Pompei G, Marchini F, Scancarello D, Pignatelli G, D'Amore SM, Colaiori I, Demola P, Di Serafino L, Tumscitz C, Penzo C, Erriquez A, Manfrini M, Campo G. QFR-Based Virtual PCI or Conventional Angiography to Guide PCI: The AQVA Trial. JACC Cardiovasc Interv. 2023 Apr 10;16(7):783-794. doi: 10.1016/j.jcin.2022.10.054. Epub 2023 Mar 8.

  PMID: 36898939 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The core-laboratory will be blinded to patients randomization during the adjudication of the endpoint
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Cardiology

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: February 20, 2021
• Primary Completion: December 27, 2021
• Study Completion: May 9, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

IT (3)