NCT04391413

Does OCT Optimise Results of Stenting on the Left Main Stem

Does Optical Coherence Tomography Optimise Results of Stenting of the Left Main Stem

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The DOCTORS-LM study will investigate the impact of using optical coherence tomography (OCT) to guide the procedure in angioplasty of lesions of the left main stem responsible for myocardial ischemia.

Detailed description

Angiographic evaluation of lesions of the left main stem presents particular challenges and high procedural complexity. The clinical sequelae of a suboptimal result in this context may be severe, and thus, it is recommended that patients with left-main lesions be considered for imaging-guided interventions by means of optimal coherence tomography (OCT) in non-ostial left main lesions. The investigators have previously demonstrated in a randomized trial of patients undergoing PCI for a lesion responsible for non ST elevation acute coronary syndromes that OCT provides useful clinical information beyond that obtained by angiography alone, and OCT-guidance for angioplasty in these patients yielded a significantly higher proportion of patients with an optimal functional result after stenting. In this context, the aim of the present study is to evaluate whether OCT-guided left-main angioplasty is superior to left main angioplasty guided by fluoroscopy alone, as assessed by fractional flow reserve (FFR) measured after stent implantation. Eligible patients must be aged 18 years and over, admitted for acute coronary syndrome (ACS) or stable coronary artery disease (CAD); AND present an angiographically significant non-ostial lesion of the left main stem requiring angioplasty with drug eluting stent implantation.

Conditions

• Myocardial Infarction
• Myocardial Ischemia
• Non ST Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Use of OCT to guide the angioplasty procedure	OCT will be performed and OCT data used to choose and/or modify procedural strategy. The OCT system used will be the Ilumien Optis system, and Dragonfly Optis probe.

Timeline

• Start date: 2020-08-07
• Primary completion: 2022-06-16
• Completion: 2023-07-16
• First posted: 2020-05-18
• Last updated: 2022-11-10

Locations

12 sites across 1 country: France