MedTrace Logo

Angio-based Fractional Flow Reserve to Predict Adverse Events After Stent Implantation

NCT02811796 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 602

Last updated 2021-04-29

No results posted yet for this study

Summary

The investigators will collect prospectively baseline, procedural and follow-up data of all patients receiving successful percutaneous coronary intervention (PCI) and stent implantation. Angio-based flow fractional reserve (quantitative flow ratio, QFR, Medis medical imaging systems Leiden, The Netherlands) will be estimated in all patients. Especially, the investigators at the end of the procedure (this is defined according operator's judgement) will record 2 orthogonal angiograms (as suggested by QFR instructions) at 15 frames/second and the same 2 orthogonal angiograms at 30 frames/second. An independent corelab (blinded to procedural data and clinical outcome) will estimate QFR value (one with the angiograms at 15 frames and one with those at 30 frames

Conditions

  • Prognosis
  • Stents

Interventions

OTHER

angio-based FFR estimation

The investigators will acquire specific angiograms to permit angio-based FFR (QFR) calculation. An independent corelab will estimate the QFR value. This value will be related to prognosis to verify if it is able to discriminate those at higher risk of adverse events.

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-07-31
Completion
2021-04-30

Countries

  • Italy
  • Spain

Study Locations

More Related Trials

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 NCT02811796 on ClinicalTrials.gov