NCT03820492 (OPTICO-LM) is a NA clinical trial of OCT, FFR, CTA and FFRCT in Coronary Stenosis, sponsored by Insel Gruppe AG, University Hospital Bern.

Who is sponsoring NCT03820492?

NCT03820492 is sponsored by Insel Gruppe AG, University Hospital Bern.

What drugs are being tested in NCT03820492?

Interventions in NCT03820492: OCT, FFR, CTA and FFRCT.

What condition does NCT03820492 study?

NCT03820492 studies Coronary Stenosis.

Is NCT03820492 still recruiting?

NCT03820492 is currently recruiting now. Last updated 9 February 2023.

Last reviewed 2023-02-09 · How we verify

NCT03820492: OPTICO-LM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

Recruiting now NA Last updated 9 February 2023

What this trial tests

NA trial testing OCT, FFR, CTA and FFRCT in Coronary Stenosis in 104 participants. Currently enrolling.

Timeline

28 May 2019

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	104
Start date	28 May 2019
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	13 locations across France, Japan, Switzerland, Germany

Drugs / interventions tested

OCT, FFR, CTA and FFRCT

Conditions studied

Coronary Stenosis — all drugs for Coronary Stenosis →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Coronary Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT. This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference standard.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Coronary Stenosis

Currently open trials in the same condition.

NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT06542393 — PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG) · Phase 2 · recruiting
NCT05709652 — Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup · NA · recruiting
NCT06376630 — Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI · NA · recruiting
NCT04014140 — iFR Guided Coronary Artery Bypass Grafting Surgery · recruiting

Other Insel Gruppe AG, University Hospital Bern trials

Trials by the same sponsor.

NCT06546384 — GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease · NA · not yet recruiting
NCT07524049 — Giving Children a Voice in Paediatric Anaesthesia · not yet recruiting
NCT07415668 — Motor Eloquent Navigated Transcranial Magnetic Stimulation for Radiosurgery Planning · NA · not yet recruiting
NCT07478536 — Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial) · not yet recruiting
NCT07201506 — Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03820492 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Insel Gruppe AG, University Hospital Bern
Last refreshed: 9 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03820492.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing