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Physiology Optimized Versus Angio-guided PCI

NCT05658952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2024-12-12

No results posted yet for this study

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

Interventions

OTHER

Microcatheter-derived FFR

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.

OTHER

Angiography-derived FFR

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.

OTHER

Angiography-guided PCI

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

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-06-20
Completion
2024-12-07

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05658952 on ClinicalTrials.gov