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COMPLETED
NCT04111770
NA

The OPTIMAL Randomized Controlled Trial

Sponsor: ECRI bv

View on ClinicalTrials.gov

Summary

The OPTIMAL study is a randomized, controlled, multicentre, international study. A total of 800 patients will be randomized in a 1:1 fashion to Intravascular Ultrasound (IVUS)-guided PCI versus qualitative angio(QCA)-guided Percutaneous Coronary Intervention (PCI). Patients will be consented prior to the PCI procedure and then followed up to 2 years after the index procedure for the last enrolled patient. Patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and yearly after (outpatient clinic visit or telephone call).

Official title: OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound. The OPTIMAL Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

806

Start Date

2020-07-08

Completion Date

2025-07-31

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DEVICE

IVUS guided Percutaneous Coronary Intervention

Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.

DEVICE

Qualitative or quantitative angiography will guide percutaneous coronary intervention

Qualitative or quantitative angiography will be used to determine lesion characteristics

Locations (28)

ASST Papa Giovanni XXIII

Bergamo, Italy

A.O.U. di Ferrara

Ferrara, Italy

Interventistica Cardiologica Strutturale

Florence, Italy

ASST Niguarda

Milan, Italy

Policlinco San Donato

Milan, Italy

Sant'Ambrogio Clinical Institute

Milan, Italy

Policlinico Umberto I

Rome, Italy

AOUI Verona

Verona, Italy

Hospital Universitario de A Coruña

A Coruña, Spain

Hospital de Bellvitge

Barcelona, Spain

Hospital Vall d´Hebron

Barcelona, Spain

Hospital Reina Sofia

Córdoba, Spain

Hospital de Cabueñes

Gijón, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Clinico Universiatrio V. Arrixaca

Murcia, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Alvaro Cunqueiro

Vigo, Spain

Hospital Clinico Lozano Blesa

Zaragoza, Spain

Royal Victoria Hospital

Belfast, United Kingdom

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Royal Sussex Country Hospital

Brighton, United Kingdom

Bristol Royal infirmary

Bristol, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Golden Jubilee National Hospital

Clydebank, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

The Freeman Hospital

Newcastle upon Tyne, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom