NCT05596279

PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

Clinical Performance of a Novel Hybrid Intravascular Ultrasound-Optical Coherence Tomography System: a Prospective Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Artery Disease
• Intravascular Imaging Device

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Intravascular ultrasound	Hybrid IVUS-OCT and control IVUS were performed after stenting
DIAGNOSTIC_TEST	Optical coherence tomography	Hybrid IVUS-OCT and control OCT were performed after stenting

Timeline

• Start date: 2019-11-20
• Primary completion: 2020-08-12
• Completion: 2021-07-30
• First posted: 2022-10-27
• Last updated: 2023-02-13

Locations

3 sites across 1 country: China