NCT05658952Completed
Physiology Optimized Versus Angio-guided PCI
Angio- or Microcatheter- Quantified FFR Virtual PCI Versus Angio-guided PCI in the Achievement of an Optimal Post-PCI FFR
Source: ClinicalTrials.gov · Last updated 12 Dec 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 305 (actual)
- First submitted
- 1 Dec 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 20 Jun 2023
- Lead sponsor
- University Hospital of Ferrara
- Diseases
- Coronary artery disease
- NCT number
- NCT05658952
What you commit to
- Study type: Interventional
- Participants enrolled: 305
- From 1 Dec 2022 to the primary completion date, 20 Jun 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgical revascularization
- Prior Coronary Artery Bypass Graft (CABG) Surgery
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Cona | Italy | Unknown status |
| Santa Maria Goretti Hospital Coordinator of this site? Confirm its status | Latina | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.