Precise Percutaneous Coronary Intervention Plan (P3) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-12-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnostic and Prognostic Utility of Pentraxin 3 in Patients With Acute STEMI Undergoing Primary PCI

NCT03476252

Myocardial Infarction

UNKNOWN NA

Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention

NCT05336669

Chronic Coronary Insufficiency Smoking

UNKNOWN

APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3

NCT00138034

Myocardial Infarction

COMPLETED PHASE4

Polymer Free Stent in Acute Coronary Syndrome

NCT03878966

Acute Coronary Syndrome

UNKNOWN NA

P3AMI Antiplatelet Trial

NCT02376283

Heart Attack

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stable Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single-arm cohort

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

FFRCT planner

Intervention Type DIAGNOSTIC_TEST

Non-invasive post-PCI fractional flow reserve prediction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FFRCT planner

Non-invasive post-PCI fractional flow reserve prediction

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HeartFlow Planner

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

1. Severely calcified lesion/vessel
2. Bifurcation lesions.
3. Ostial lesions.
4. Left main disease.
5. Severe vessel tortuosity.

1. Chronic obstructive pulmonary disease
2. Contraindication to adenosine
3. NYHA class III or IV, or last known left ventricular ejection fraction \<30%
4. Uncontrolled or recurrent ventricular tachycardia
5. Atrial fibrillation, flutter or arrhythmia
6. History of recent stroke (≤90 days)
7. History of acute coronary syndrome (≤90 days)
8. Prior myocardial infarction
9. History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2
10. History of any hemorrhagic stroke
11. Previous revascularization (PCI or Coronary artery bypass grafting)
12. Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN
13. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2
14. Body mass index\>35 kg/m2
15. Nitrate intolerance
16. Contra-indication to heart rate lowering drugs

Imaging-related
17. Insufficient coronary CT Angiography image quality.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No