NCT04111770

The OPTIMAL Randomized Controlled Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 806 (actual)
• Sponsor: ECRI bv · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-07-08
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2019-10-01
• Last updated: 2026-02-06

Locations

28 sites across 3 countries: Italy, Spain, United Kingdom