Precise Percutaneous Coronary Intervention Plan (P3) Study

NCT03782688 | Completed DMC

• 1 other identifier: CVBA-CRI_0001
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.

  The agreement will be assessed by Bland Altman method

  The primary endpoint will be assessed immediately after the procedure (PCI).

Study Arms (1)

Single-arm cohort

Patients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80)

Diagnostic Test: FFRCT planner

Interventions

FFRCT planner DIAGNOSTIC_TEST

Non-invasive post-PCI fractional flow reserve prediction

Also known as: HeartFlow Planner

Single-arm cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Stable Coronary Artery Disease with Positive Fractional Flow Reserve and indication for percutaneous myocardial revascularization.

You may qualify if:

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

You may not qualify if:

• Severely calcified lesion/vessel
• Bifurcation lesions.
• Ostial lesions.
• Left main disease.
• Severe vessel tortuosity.
• Chronic obstructive pulmonary disease
• Contraindication to adenosine
• NYHA class III or IV, or last known left ventricular ejection fraction \<30%
• Uncontrolled or recurrent ventricular tachycardia
• Atrial fibrillation, flutter or arrhythmia
• History of recent stroke (≤90 days)
• History of acute coronary syndrome (≤90 days)
• Prior myocardial infarction
• History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2
• History of any hemorrhagic stroke

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead

Study Sites (1)

OLV-Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

Related Publications (6)

• Seki R, Collison D, Ikeda K, Sonck J, Munhoz D, Bertolone DT, Ko B, Maeng M, Otake H, Koo BK, Storozhenko T, Bouisset F, Belmonte M, Leone A, Shumkova M, Ford TJ, Mahendiran T, Berry C, De Bruyne B, Oldroyd K, Sakai K, Mizukami T, Collet C. Validation of virtual fractional flow reserve pullback curves. Catheter Cardiovasc Interv. 2024 Nov;104(6):1178-1188. doi: 10.1002/ccd.31222. Epub 2024 Sep 29.

  PMID: 39342486 DERIVED

• Yang S, Hwang D, Sakai K, Mizukami T, Leipsic J, Belmonte M, Sonck J, Norgaard BL, Otake H, Ko B, Maeng M, Moller Jensen J, Buytaert D, Munhoz D, Andreini D, Ohashi H, Shinke T, Taylor CA, Barbato E, De Bruyne B, Collet C, Koo BK. Predictors for Vulnerable Plaque in Functionally Significant Lesions. JACC Cardiovasc Imaging. 2025 Feb;18(2):195-206. doi: 10.1016/j.jcmg.2024.07.021. Epub 2024 Sep 11.

  PMID: 39269415 DERIVED

• Candreva A, Gallo D, Munhoz D, Rizzini ML, Mizukami T, Seki R, Sakai K, Sonck J, Mazzi V, Ko B, Norgaard BL, Jensen JM, Maeng M, Otake H, Koo BK, Shinke T, Aben JP, Andreini D, Gallinoro E, Stahli BE, Templin C, Chiastra C, De Bruyne B, Morbiducci U, Collet C. Influence of intracoronary hemodynamic forces on atherosclerotic plaque phenotypes. Int J Cardiol. 2024 Mar 15;399:131668. doi: 10.1016/j.ijcard.2023.131668. Epub 2023 Dec 22.

  PMID: 38141723 DERIVED

• Sakai K, Mizukami T, Leipsic J, Belmonte M, Sonck J, Norgaard BL, Otake H, Ko B, Koo BK, Maeng M, Jensen JM, Buytaert D, Munhoz D, Andreini D, Ohashi H, Shinke T, Taylor CA, Barbato E, Johnson NP, De Bruyne B, Collet C. Coronary Atherosclerosis Phenotypes in Focal and Diffuse Disease. JACC Cardiovasc Imaging. 2023 Nov;16(11):1452-1464. doi: 10.1016/j.jcmg.2023.05.018. Epub 2023 Jul 19.

  PMID: 37480908 DERIVED

• Mizukami T, Sonck J, Sakai K, Ko B, Maeng M, Otake H, Koo BK, Nagumo S, Norgaard BL, Leipsic J, Shinke T, Munhoz D, Mileva N, Belmonte M, Ohashi H, Barbato E, Johnson NP, De Bruyne B, Collet C. Procedural Outcomes After Percutaneous Coronary Interventions in Focal and Diffuse Coronary Artery Disease. J Am Heart Assoc. 2022 Dec 6;11(23):e026960. doi: 10.1161/JAHA.122.026960. Epub 2022 Nov 29.

  PMID: 36444858 DERIVED

• Sonck J, Nagumo S, Norgaard BL, Otake H, Ko B, Zhang J, Mizukami T, Maeng M, Andreini D, Takahashi Y, Jensen JM, Ihdayhid A, Heggermont W, Barbato E, Mileva N, Munhoz D, Bartunek J, Updegrove A, Collinsworth A, Penicka M, Van Hoe L, Leipsic J, Koo BK, De Bruyne B, Collet C. Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography. JACC Cardiovasc Imaging. 2022 Jul;15(7):1242-1255. doi: 10.1016/j.jcmg.2022.02.003. Epub 2022 Apr 13.

  PMID: 35798401 DERIVED

Study Officials

• Bernard De Bruyne, MD, PhD

  OLV-Aalst

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director Cardiovascular Center OLV-Aalst

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 20, 2018
• Study Start: February 1, 2019
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2021
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

BE (1)