Intravascular ultrasound
Diagnostic TestHybrid IVUS-OCT and control IVUS were performed after stenting
NCT Number: NCT05596279
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The lesion-related exclusion criteria:
Patients-level exclusion criteria:
Hybrid IVUS-OCT and control IVUS were performed after stenting
Hybrid IVUS-OCT and control OCT were performed after stenting
Time frame: During the procedure
The CSCR detected was defined as the ratio of the clear stent length to the total stent length
Time frame: During the procedure
Measured by IVUS, OCT and hybrid IVUS-OCT
Time frame: During the procedure
Assessed by IVUS, OCT and hybrid IVUS-OCT
Time frame: During the procedure
Device success is defined as well-manipulated and capable of acquiring intravascular images
Time frame: Periprocedure
Coronary spasm, acute vessel occlusion, coronary dissection, or thrombosis
Harbin Medical University
Other
Clinical Performance of a Novel Hybrid Intravascular Ultrasound-Optical Coherence Tomography System: a Prospective Randomized Controlled Clinical Trial
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