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Automated Algorithm Detecting Physiologic Major Stenosis and Its Relationship With Post-PCI Clinical Outcomes

NCT04304677 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 486

Last updated 2022-10-26

No results posted yet for this study

Summary

The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Therefore, the purpose of percutaneous coronary intervention (PCI) is to relieve myocardial ischemia caused by the target stenosis. Fractional flow reserve (FFR) is an invasive physiologic index used to define functionally significant coronary stenosis, and its prognostic implications are supported by numerous studies. Contrary to the clear cutoff value and the benefit of FFR in pre-PCI evaluation, there have been various results regarding optimal cut-off values for post-PCI FFR. Nevertheless, the positive association between post-PCI FFR and the risk of future events has been reproduced by several studies.

PCI with stent implantation is basically a local treatment and post-PCI FFR reflects both residual stenosis in the stented segment and remaining disease beyond the stented segment in the target vessel(s).

Therefore, post-PCI FFR alone cannot fully discriminate the degree of contribution of each component. The relative increase of FFR with PCI is determined by the interaction of baseline severity of a target lesion, baseline disease burden of a target vessel, adequacy of PCI and residual disease burden in a target vessel.

However, the most important problem in stratifying patients with better expected post-PCI physiologic results and following clinical outcome would be that there has been no clear method to identify these patients in pre-PCI phase.

In this regard, we hypothesized that the amount of FFR step-up in pre-PCI pullback recording would determine the physiologic nature of target stenosis. For example, stenosis with sufficient step-up of FFR would deserve local treatment with PCI and these lesions would result in higher percent FFR increase, post-PCI FFR, and better clinical outcome than those without sufficient amount of FFR step-up.

For this, we sought to develop automated algorithm to define physiologic major stenosis versus minor stenosis using pre-PCI pullback recording.

Conditions

  • Ischemic Heart Disease

Interventions

DEVICE

Percutaneous coronary intervention

1. Pre-PCI FFR pullback recording was done with conventional system 2. Automated algorithm to calculate delta FFR per unit time was developed 3. PCI was performed using 2nd generation DES

Sponsors & Collaborators

  • Inje University Ilsan Paik Hospital

    collaborator OTHER

  • Keimyung University Dongsan Medical Center

    collaborator OTHER

  • Ulsan University Hospital

    collaborator OTHER

  • Sejong General Hospital

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Samsung Medical Center

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-22
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04304677 on ClinicalTrials.gov