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The OPTIMAL Randomized Controlled Trial

NCT04111770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2026-02-06

No results posted yet for this study

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).

Conditions

  • Left Main Coronary Artery Stenosis

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

Sponsors & Collaborators

  • Philips Healthcare

    collaborator INDUSTRY

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Cardialysis B.V.

    collaborator INDUSTRY

  • ECRI bv

    lead INDUSTRY

Principal Investigators

  • Adrian Banning, Prof · Oxford University Hospitals NHS Trust

  • Luca Testa, Dr. · Policlinco San Donato

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Italy
  • Spain
  • United Kingdom

Study Locations

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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 NCT04111770 on ClinicalTrials.gov