Actively Recruiting

Age: 18Years +
All Genders
NCT06255678

Angio-based Final Functional Effect of PCI

Led by Medical University of Warsaw · Updated on 2024-02-13

2005

Participants Needed

1

Research Sites

182 weeks

Total Duration

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AI-Summary

What this Trial Is About

Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional optimization of the implanted stent. Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve (vFFR) and derivative ΔvFFR, which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR. In large clinical studies, the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed. However, insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health. This is a prospective multicenter register study analyzing the association between the value of ΔvFFR, vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study.

CONDITIONS

Official Title

Angio-based Final Functional Effect of PCI

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
  • Angiogram of adequate quality allowing vFFR analysis (two views with at least 30° difference, proper image quality, no severe overlapping or poor vessel opacification)
  • Age older than 18 years
  • Written informed consent obtained before the procedure
Not Eligible

You will not qualify if you...

  • Cardiogenic shock or pulmonary edema
  • Severe hemodynamical instability
  • Prior coronary artery bypass grafting (CABG)
  • Active bleeding
  • Acute and chronic inflammatory conditions
  • Acute mechanical complications of myocardial infarction
  • Congenital heart disease
  • Heart transplantation
  • Non-cardiac conditions with life expectancy less than 1 year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of Warsaw

Warsaw, Poland, 02-097

Actively Recruiting

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Research Team

M

Mariusz Tomaniak, MD PhD

CONTACT

K

Karol Sadowski

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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