Precise Percutaneous Coronary Intervention Plan (P3) Study | NCT03782688

Studies
Precise Percutaneous Coronary Intervention Plan (P3) Study

NCT03782688

Sponsor

Onze Lieve Vrouw Hospital

Status

Completed

Last Update Posted

Mar 23, 2023Actual

Enrollment

127Actual

Phase

Not provided

Conditions

Stable Coronary Artery Disease

Interventions

FFRCT planner

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Dec 18, 2020Actual

Completion Date

Dec 18, 2021Actual

First Submitted Date

Dec 12, 2018

First Submission Date that Met QC Criteria

Dec 19, 2018

First Posted Date

Dec 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2023

Last Update Posted Date

Mar 23, 2023Actual

Description Module

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.

Label	Type	Description	Intervention Names
Single-arm cohort		Patients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80)	Diagnostic Test: FFRCT planner

Name	Type	Description	Arm Group Labels	Other Names
FFRCT planner	Diagnostic Test	Non-invasive post-PCI fractional flow reserve prediction	Single-arm cohort

Measure	Description	Time Frame
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).

Eligibility Module

Eligibility Criteria

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 exclusion criteria

Severely calcified lesion/vessel
Bifurcation lesions.
Ostial lesions.
Left main disease.
Severe vessel tortuosity.

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bernard De Bruyne, MD, PhD	OLV-Aalst	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
OLV-Aalst		Aalst	Oost-Vlaanderen	9300	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39342486	Derived	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.
39269415