Status:

ACTIVE_NOT_RECRUITING

Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR

Lead Sponsor:

Fundación EPIC

Conditions:

Coronary Artery Disease

Left Main Coronary Artery Stenosis

Eligibility:

All Genders

18+ years

Brief Summary

The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. Studies with a limited number of patients have shown that a value of FFR (Frac...

Detailed Description

The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. In the case of intermediate stenoses (25-60%), invasive imaging tests, intravas...

Eligibility Criteria

Inclusion

  • Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual estimation) in which the realization of a study with guide of pressure for the determination of the iFR.
  • Patients aged ≥18 years.
  • Patients able of giving informed consent.

Exclusion

  • Patients with indication for coronary surgery regardless of the significance of the LMCA lesion.
  • Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.
  • Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected).
  • Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA.
  • Patients unable to obtain informed consent.
  • Patients with known terminal illness that conditions a life expectancy less than 1 year.
  • Patients with hemodynamic instability with Killip III or IV class.

Key Trial Info

Start Date :

February 19 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 30 2026

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT03767621

Start Date

February 19 2019

End Date

November 30 2026

Last Update

March 5 2025

Active Locations (38)

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Page 1 of 10 (38 locations)

1

Hospital Universitari Mutua de Terrassa

Terrassa, Barcelona, Spain, 08221

2

Hospital General Universitario de Santa Lucia de Cartagena

Cartagena, Murcia, Spain, 30202

3

Hospital Clinico Universitario Virgen de La Arrixaca

El Palmar, Murcia, Spain, 30120

4

Hospital General Universitario de Castellón

Castellon, Valencia, Spain, 12004