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PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

NCT05596279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Second Hospital of Jilin University

    collaborator OTHER

  • Wuhan Asia Heart Hospital

    collaborator OTHER

  • Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.

    collaborator UNKNOWN

  • Harbin Medical University

    lead OTHER

Principal Investigators

  • Bo Yu, MD, PhD · The Second Affiliated Hospital of Harbin Medical University

  • Bin Liu, MD, PhD · Second Hospital of Jilin University

  • Xi Su, MD, PhD · Wuhan Asia Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2020-08-12
Completion
2021-07-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05596279 on ClinicalTrials.gov