Coronary Artery Disease, Intravascular Imaging Device
Conditions
Keywords
Hybrid imaging, Intravascular ultrasound, Optical coherence tomography
Brief 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.
Interventions
DIAGNOSTIC_TESTIntravascular ultrasound
Hybrid IVUS-OCT and control IVUS were performed after stenting
DIAGNOSTIC_TESTOptical coherence tomography
Hybrid IVUS-OCT and control OCT were performed after stenting
Sponsors
Second Hospital of Jilin University
Wuhan Asia Heart Hospital
Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.
Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years * Patients eligible for elective percutaneous coronary intervention * Understand and voluntarily sign the informed consent form
Exclusion criteria
The lesion-related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clear stent capture rate (CSCR) | During the procedure | The CSCR detected was defined as the ratio of the clear stent length to the total stent length |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with clear image length ≥ 24mm | During the procedure | Measured by IVUS, OCT and hybrid IVUS-OCT |
| Detection rate of edge dissection, tissue prolapse and stent malapposition | During the procedure | Assessed by IVUS, OCT and hybrid IVUS-OCT |
| Device success rate | During the procedure | Device success is defined as well-manipulated and capable of acquiring intravascular images |
| Adverse procedure-related adverse cardiovascular events | Periprocedure | Coronary spasm, acute vessel occlusion, coronary dissection, or thrombosis |
Countries
China
Outcome results
None listed