Precise Percutaneous Coronary Intervention Plan (P3) Study

Conditions

Stable Coronary Artery Disease

Brief summary

The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference.

Detailed description

Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying the presence of significant coronary stenosis by means of coronary angiography and invasive fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures: Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation drug-eluting stent.

Stalikas N, Mizukami T, Bouisset F, Ikeda K, Tajima A, Munhoz D, Mahendiran T, Wilgenhof A, Sakai K, Noorgard B, Engstroem T, Leipsic J, Stefanini G, Bartorelli A, Fairbairn T, Bagnall A, Ko B, Johnson NP, Berry C, Perera D, Christiansen EH, Shinke T, Otake H, Koo BK, Barbato E, Brugaletta S, Collison D, Campo G, Van Belle E, Goori T, Van Nunen L, Witkowski A, Astudillo P, Spratt J, Amano T, Ando H, Sianos G, Sonck J, Andreini D, De Bruyne B, Collet C.

2025-11-06

10.1161/jaha.124.039013

Predictors for Vulnerable Plaque in Functionally Significant Lesions.

Yang S, Hwang D, Sakai K, Mizukami T, Leipsic J, Belmonte M, Sonck J, Nørgaard BL, Otake H, Ko B, Maeng M, Møller Jensen J, Buytaert D, Munhoz D, Andreini D, Ohashi H, Shinke T, Taylor CA, Barbato E, De Bruyne B, Collet C, Koo BK.

2024-09-119 citations

10.1016/j.jcmg.2024.07.021

Stent sizing by coronary CT angiography compared with optical coherence tomography.

Ko B, Ohashi H, Mizukami T, Sakai K, Sonck J, Nørgaard BL, Maeng M, Jensen JM, Ihdayhid A, Tajima A, Ando H, Amano T, De Bruyne B, Koo BK, Otake H, Collet C.

2024-05-235 citations

10.1016/j.jcct.2024.03.002

Intravascular Imaging Findings After PCI in Patients With Focal and Diffuse Coronary Artery Disease

Hirofumi Ohashi, Takuya Mizukami, Jeroen Sonck, Frédéric Bouisset, Brian Ko et al. (17 authors)

Journal of the American Heart Association2024-02-2312 citations

10.1161/jaha.123.032605

Influence of intracoronary hemodynamic forces on atherosclerotic plaque phenotypes.

Candreva A, Gallo D, Munhoz D, Rizzini ML, Mizukami T, Seki R, Sakai K, Sonck J, Mazzi V, Ko B, Nørgaard BL, Jensen JM, Maeng M, Otake H, Koo BK, Shinke T, Aben JP, Andreini D, Gallinoro E, Stähli BE, Templin C, Chiastra C, De Bruyne B, Morbiducci U, Collet C.

2023-12-227 citations

10.1016/j.ijcard.2023.131668

Coronary Atherosclerosis Phenotypes in Focal and Diffuse Disease

Koshiro Sakai, Takuya Mizukami, Jonathon Leipsic, Marta Belmonte, Jeroen Sonck et al. (21 authors)

JACC. Cardiovascular imaging2023-07-1953 citations

10.1016/j.jcmg.2023.05.018

483 CORONARY ATHEROSCLEROSIS PHENOTYPES IN FOCAL AND DIFFUSE DISEASE

Marta Belmonte, Koshiro Sakai, Takuya Mizukami, Jonathon Leipsic, Jeroen Sonck et al. (15 authors)

European Heart Journal Supplements2022-12-141 citations

10.1093/eurheartjsupp/suac121.290

Procedural Outcomes After Percutaneous Coronary Interventions in Focal and Diffuse Coronary Artery Disease

Takuya Mizukami, Jeroen Sonck, Koshiro Sakai, Brian Ko, Michael Mæng et al. (19 authors)

Journal of the American Heart Association2022-11-2937 citations

10.1161/jaha.122.026960

Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography

Jeroen Sonck, Sakura Nagumo, Bjarne Linde Nørgaard, Hiromasa Otake, Brian Ko et al. (25 authors)

JACC. Cardiovascular imaging2022-04-1390 citations

10.1016/j.jcmg.2022.02.003

Interventions

DIAGNOSTIC_TESTFFRCT planner

Non-invasive post-PCI fractional flow reserve prediction

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80 * An indication to Percutaneous coronary intervention

Exclusion criteria

\- Angiographic

Design outcomes

Primary

Measure	Time frame	Description
Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.	The primary endpoint will be assessed immediately after the procedure (PCI).	The agreement will be assessed by Bland Altman method

Countries

Belgium

Outcome results

None listed