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NCT04265443: PERSPECTIVEPCI

Prognostic Perspective of Invasive Hyperemic and Non-Hyperemic Physiologic Indices Measured After Percutaneous Coronary Intervention

Completed Last updated 26 October 2022
What this trial tests

trial testing Percutaneous coronary intervention in Ischemic Heart Disease in 588 participants. Completed in 1 October 2022.

Timeline
13 May 2013
Primary endpoint
1 October 2022
1 October 2022

Quick facts

Lead sponsorSamsung Medical Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment588
Start date13 May 2013
Primary completion1 October 2022
Estimated completion1 October 2022
Sites5 locations across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Samsung Medical Center

Who can join

Adults 20 to 85, any sex, with Ischemic Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Coronary physiologic assessments by the pressure-derived fractional flow reserve (FFR) have become standard methods for identifying hemodynamic deprivation in coronary arterial stenosis for evidence-based percutaneous coronary intervention (PCI). Invasive physiologic indices-guidance enables on-site real time assessment for functional significance of epicardial coronary stenosis and the use of those indices has shown to be effective to guide treatment decision. Several studies further support the role of post-PCI FFR measurement as a functional marker of residual disease after PCI and prognostic indicator of patients. Although optimal cut-off values of post-PCI FFR varied across studies, an inverse relationship between post-PCI FFR and the risk of future clinical events have been reported consistently. Recently, non-hyperemic pressure ratios (NHPRs) have been introduced in clinical practice. Although there are several different NHPRs, previous studies consistently indicated that those NHPRs shares similar diagnostic performance and prognostic implications. Nevertheless, few reports were available for clinical relevance of NHPRs in evaluation of post-PCI status. In this context, we will evaluate the physiologic characteristics and prognostic implication of post-PCI NHPRs and compare with those of post-PCI FFR in patients who underwent angiographically successful PCI with 2nd generation drug-eluting stent implantation (DES).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Prognostic Implications of Post-Intervention Resting Pd/Pa and Fractional Flow Reserve in Patients With Stent Implantation.
    Shin D, Lee SH, Lee JM, Choi KH, et al · · 2020 · cited 25× · PMID 32819481 · DOI 10.1016/j.jcin.2020.05.042
  2. Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice.
    Lee JM, Joh HS, Choi KH, Hong D, et al · · 2023 · cited 2× · PMID 36747363 · DOI 10.3346/jkms.2023.38.e34

Verify or expand the search:

Other trials of Percutaneous coronary intervention

Trials testing the same drug.

Other recruiting trials for Ischemic Heart Disease

Currently open trials in the same condition.

Other Samsung Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing