NCT05596279

PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

Completed NA Last updated 13 February 2023

What this trial tests

NA trial testing Intravascular ultrasound in Coronary Artery Disease in 100 participants. Completed in 30 July 2021.

Timeline

20 November 2019

Primary endpoint
12 August 2020

30 July 2021

Quick facts

Lead sponsor	Harbin Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	20 November 2019
Primary completion	12 August 2020
Estimated completion	30 July 2021
Sites	3 locations across China

Drugs / interventions tested

• Intravascular ultrasound
• Optical coherence tomography

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Intravascular Imaging Device — all drugs for Intravascular Imaging Device →

Sponsor

Harbin Medical University

Who can join

Adults 18 to 75, any sex, with Coronary Artery Disease or Intravascular Imaging Device. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were all recommended for percutaneous coronary intervention (PCI) optimization in the latest guidelines, however, which imaging modality was more suitable as either a diagnostic or guidance tool was still unknown. Recently, a novel, well-designed hybrid imaging system was approved for clinical use, allowing the accurate co-registration of two imaging modalities and immediate, simultaneous image review. For testing each modality in the hybrid imaging system, the investigators conducted this prospective, multicentre, non-inferiority trial. In this study, all participants achieved hybrid IVUS-OCT imaging after stenting, at meanwhile, patients randomly assigned to the IVUS arm were performed control IVUS (OptiCross, Boston Scientific, Natick, MA), and patients randomly assigned to the OCT arm were performed control OCT (C7 Dragonfly Duo, St. Jude Medical, St. Paul, MN). In this study, the investigators evaluated the non-inferiority of standalone IVUS versus control IVUS or standalone OCT versus control OCT in clinical feasibility using clear stent capture rate (CSCR) and safety using perioperative device-related adverse cardiovascular events.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical performance of a novel hybrid IVUS-OCT system: a multicentre, randomised, non-inferiority trial (PANOVISION).
   Jia H, Zhao C, Yu H, Wang Z, et al · · 2023 · cited 13× · PMID 37057604 · DOI 10.4244/eij-d-22-01058