Physiology Optimized Versus Angio-guided PCI

NCT05658952 | Completed DMC

• 1 other identifier: 828/2022/DispAOUFe
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

Percutaneous coronary intervention; Fractional Flow Reserve; Virtual PCI plan

Outcome Measures

Primary Outcomes (1)

• Post-PCI Fractional Flow Reserve (FFR)

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

  at the end of the procedure (at the moment of the last angiography)

Secondary Outcomes (2)

• VOCE

  1 year

• Post-PCI Distal Pressure (Pd) / Aortic Pressure (Pa)

  at the end of the procedure (at the moment of the last angiography)

Study Arms (3)

Angiography-guided PCI

ACTIVE COMPARATOR

Patients will receive PCI according to the interpretation of angiography findings by the Interventional Cardiologist.

Other: Angiography-guided PCI

Microcatheter-derived FFR

EXPERIMENTAL

Patients will receive PCI according to the plan derived from the interpretation of the FFR pullback obtained with microcatheter FFR performed by the Interventional Cardiologist before and after PCI.

Other: Microcatheter-derived FFR

Angiography-derived FFR

EXPERIMENTAL

Patients will receive PCI according to the plan derived from the interpretation of the FFR pullback obtained with angiography-derived FFR performed by the Interventional Cardiologist before PCI. The angiography-derived FFR can be repeated after PCI to check the results and eventually apply correcting maneuvers.

Other: Angiography-derived FFR

Interventions

Microcatheter-derived FFR OTHER

FFR pullback trace is obtained through the manual retrieval performed after the positioning of the microcatheter FFR in the distal portion of the vessel. The pullback speed should be steady and the overall duration would be between 20 and 40 seconds. Then, the Interventional Cardiologist has to decide the procedural plan according to the pullback trace aiming to obtain an optimal post-PCI result in terms of physiology. FFR with pullback can be repeated after stenting to check and correct the result if needed.

Microcatheter-derived FFR

Angiography-derived FFR OTHER

FFR pullback trace is automatically obtained after the 3-Dimensional reconstruction of the vessel through angiography derived FFR. Then, Interventional Cardiologist has to decide the procedural plan according to the pullback result aiming to obtain an optimal post-PCI result in terms of physiology. Angiography-derived FFR can be repeated after stenting to check and correct the result if needed.

Angiography-derived FFR

Angiography-guided PCI OTHER

Interventional Cardiologist will perform PCI plan according to his/her the evaluation of angiography.

Angiography-guided 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (2)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Santa Maria Goretti Hospital

Latina, LT, Italy

Location

Related Publications (2)

• Biscaglia S, Verardi FM, Erriquez A, Colaiori I, Cocco M, Cantone A, Pompei G, Marrone A, Caglioni S, Tumscitz C, Penzo C, Manfrini M, Leone AM, Versaci F, Campo G. Coronary Physiology Guidance vs Conventional Angiography for Optimization of Percutaneous Coronary Intervention: The AQVA-II Trial. JACC Cardiovasc Interv. 2024 Jan 22;17(2):277-287. doi: 10.1016/j.jcin.2023.10.032. Epub 2023 Oct 23.

  PMID: 37902150 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

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair

Model Details: two nested, randomized, multicenter, open-label trials

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 21, 2022
• Study Start: December 1, 2022
• Primary Completion: June 20, 2023
• Study Completion: December 7, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)