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Precise Percutaneous Coronary Intervention Plan (P3) Study

Sponsor
Onze Lieve Vrouw Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03782688
Collaborator
(none)
127
Enrollment
1
Location
34.5
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: FFRCT planner

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
127 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Dec 18, 2020
Anticipated Study Completion Date :
Dec 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Single-arm cohort

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

Diagnostic Test: FFRCT planner
Non-invasive post-PCI fractional flow reserve prediction
Other Names:
  • HeartFlow Planner

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    1. Severely calcified lesion/vessel

    2. Bifurcation lesions.

    3. Ostial lesions.

    4. Left main disease.

    5. Severe vessel tortuosity.

    Clinical exclusion criteria

    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

    1. Insufficient coronary CT Angiography image quality.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OLV-Aalst Aalst Oost-Vlaanderen Belgium 9300

    Sponsors and Collaborators

    • Onze Lieve Vrouw Hospital

    Investigators

    • Study Chair: Bernard De Bruyne, MD, PhD, OLV-Aalst

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeroen Sonck, Co-Director Cardiovascular Center OLV-Aalst, Onze Lieve Vrouw Hospital
    ClinicalTrials.gov Identifier:
    NCT03782688
    Other Study ID Numbers:
    • CVBA-CRI_0001
    First Posted:
    Dec 20, 2018
    Last Update Posted:
    Feb 25, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease

    Study Results

    No Results Posted as of Feb 25, 2021