Stable Coronary Artery DiseaseP3NCT03782688
Precise Percutaneous Coronary Intervention Plan (P3) Study
An observational study of Stable Coronary Artery Disease, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Coronary Artery Disease
- What is being tested?
- FFRCT planner
- How many people
- 127 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2019to 18 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with Stable Coronary Artery Disease with Positive Fractional Flow Reserve and indication for percutaneous myocardial revascularization.
Who may be able to join
- Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80
- An indication to Percutaneous coronary intervention
Who cannot join
- Angiographic exclusion criteria
- Severely calcified lesion/vessel
- Bifurcation lesions.
- Ostial lesions.
- Left main disease.
- Severe vessel tortuosity.
Show all 25Show fewer
- Clinical exclusion criteria
- 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
- Previous revascularization (PCI or Coronary artery bypass grafting)
- Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN
- Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2
- Body mass index>35 kg/m2
- Nitrate intolerance
- Contra-indication to heart rate lowering drugs
- Imaging-related
- Insufficient coronary CT Angiography image quality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.
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.
Read the 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.
- Conditions
- Stable Coronary Artery Disease
- Being tested
- FFRCT planner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFRCT plannerDiagnostic test
Also called HeartFlow Planner
Non-invasive post-PCI fractional flow reserve prediction
| Study group | Role | What they receive |
|---|---|---|
| Single-arm cohort | Patients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80) Receives: Diagnostic Test: FFRCT planner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The primary endpoint will be assessed immediately after the procedure (PCI).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Feb 2019
- Primary completion18 Dec 2020
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeroen Sonck, Onze Lieve Vrouw Hospital
- Investigators
- Bernard De Bruyne, MD, PhD, Study chair, OLV-Aalst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782688
- Sponsor's protocol ID
- CVBA-CRI_0001
- Acronym
- P3
- Status last verified
- Mar 2023
- First submitted
- 12 Dec 2018
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided plan for data sharing
Publications
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.
PubMed 39342486Yang 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.
PubMed 39269415Candreva 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.
PubMed 38141723Sakai 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.
PubMed 37480908Mizukami 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.
PubMed 36444858Sonck 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.
PubMed 35798401
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT03782688
- Acronym / sponsor ID
- P3 / CVBA-CRI_0001
- Conditions
- Stable Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Onze Lieve Vrouw HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm cohort | – | Diagnostic Test: FFRCT plannerPatients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Stable Coronary Artery Disease with Positive Fractional Flow Reserve and indication for percutaneous myocardial revascularization.
Key inclusion criteria (2 listed)
- Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80
- An indication to Percutaneous coronary intervention
Key exclusion criteria (25 listed)
- Angiographic exclusion criteria
- Severely calcified lesion/vessel
- Bifurcation lesions.
- Ostial lesions.
- Left main disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFRCT plannerAlso: HeartFlow PlannerNon-invasive post-PCI fractional flow reserve prediction | Diagnostic test | Single-arm cohort |
Primary outcome
Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.
Time frame: The primary endpoint will be assessed immediately after the procedure (PCI).
The agreement will be assessed by Bland Altman method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 39342486Seki 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.
- Derived from this study: PubMed 39269415Yang 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.
- Derived from this study: PubMed 38141723Candreva 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.
- Derived from this study: PubMed 37480908Sakai 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.
- Derived from this study: PubMed 36444858Mizukami 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.
- Derived from this study: PubMed 35798401Sonck 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.
- Individual participant dataSharing planned: Undecided. Undecided plan for data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard De Bruyne, MD, PhD study chair
OLV-Aalst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Coronary Artery Disease, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve. (time frame: The primary endpoint will be assessed immediately after the procedure (PCI).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03782688, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023; AzTrials last refreshed its copy on 26 Oct 2026.