Percutaneous Coronary Intervention Clinical Trial
— AQVAOfficial title:
Angio-based Quantitative Flow Ratio Virtual PCI Versus Conventional Angio-guided PCI in the Achievement of an Optimal Post-PCI QFR
Verified date | May 2023 |
Source | University Hospital of Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | May 9, 2023 |
Est. primary completion date | December 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Indication to PCI for either acute or chronic coronary syndrome - Signed informed consent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital of Ferrara | Cona | Ferrara |
Italy | University Hospital Federico II | Napoli | |
Italy | Azienda Ospedaliera Santa Maria | Reggio Emilia |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | post-PCI QFR | proportion of patients with a final post-PCI QFR result =0.90 | end of the procedure | |
Secondary | vessel-oriented composite endpoint (VOCE) | composite of vessel-related cardiovascular death, vessel-related MI, and ischemia-driven target vessel revascularization (TVR) | 1 year |
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