Ignite Creation Date:
2024-05-06 @ 6:14 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05596279
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2022-10-20
Brief Title:
PANOVISION Feasibility and Safety of Hybrid IVUS-OCT System
Sponsor:
Harbin Medical University
Organization:
Harbin Medical University
Study Overview
Official Title:
Clinical Performance of a Novel Hybrid Intravascular Ultrasound-Optical Coherence Tomography System a Prospective Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None