NCT03767621Active, 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
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 (iLITRO Study)
Source: ClinicalTrials.gov · Last updated 5 Mar 2025
Brief summary (registry, in English)
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 (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 2 Dec 2018
- Start date
- 19 Feb 2019
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Fundación EPIC
- Diseases
- Coronary artery disease
- NCT number
- NCT03767621
What you commit to
- Study type: Observational
- Planned participants: 300
- From 19 Feb 2019 to the primary completion date, 30 Jun 2026
- 38 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with indication for coronary surgery regardless of the significance of the LMCA lesion.
- Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected).
Other illness
- Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA.
- Patients with known terminal illness that conditions a life expectancy less than 1 year.
Other
- Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.
- Patients unable to obtain informed consent.
- Patients with hemodynamic instability with Killip III or IV class.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Unknown status |
| Hospital Universitari Germans Trias i Pujol de Badalona Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Bellvitge Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clínic i Provincial de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Puerto Real Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Hospital General Universitario de Santa Lucia de Cartagena Coordinator of this site? Confirm its status | Cartagena | Spain | Unknown status |
| Hospital General Universitario de Castellón Coordinator of this site? Confirm its status | Castellon | Spain | Unknown status |
| Hospital General de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital Galdakao-Usansolo Coordinator of this site? Confirm its status | Galdakao | Spain | Unknown status |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Unknown status |
| Hospital Universitari Doctor Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital General Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Hospital de León Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital Universitari Lucus Agusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hospital Universitario de la Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clínica Universitaria de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital de La Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital de Mérida Coordinator of this site? Confirm its status | Mérida | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitario de Donostia Coordinator of this site? Confirm its status | San Sebastián | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Clínico Universitario de Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital Universitari Joan XXIII de Tarragona Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
| Hospital Universitari Mútua de Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| Hospital Universitario Virgen de La Salud Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.