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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Hybrid IVUS-OCT and control IVUS were performed after stenting
Hybrid IVUS-OCT and control OCT were performed after stenting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Clear stent capture rate (CSCR)
The CSCR detected was defined as the ratio of the clear stent length to the total stent length
Time frame: During the procedure
Proportion of patients with clear image length ≥ 24mm
Measured by IVUS, OCT and hybrid IVUS-OCT
Time frame: During the procedure
Detection rate of edge dissection, tissue prolapse and stent malapposition
Assessed by IVUS, OCT and hybrid IVUS-OCT
Time frame: During the procedure
Device success rate
Device success is defined as well-manipulated and capable of acquiring intravascular images
Time frame: During the procedure
Adverse procedure-related adverse cardiovascular events
Coronary spasm, acute vessel occlusion, coronary dissection, or thrombosis
Time frame: Periprocedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.