PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

NCT05596279 | Completed

• 1 other identifier: VP-3003-1901
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Artery Disease; Intravascular Imaging Device

Keywords

Hybrid imaging; Intravascular ultrasound; Optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Clear stent capture rate (CSCR)

  The CSCR detected was defined as the ratio of the clear stent length to the total stent length

  During the procedure

Secondary Outcomes (4)

• Proportion of patients with clear image length ≥ 24mm

  During the procedure

• Detection rate of edge dissection, tissue prolapse and stent malapposition

  During the procedure

• Device success rate

  During the procedure

• Adverse procedure-related adverse cardiovascular events

  Periprocedure

Study Arms (2)

Intravascular ultrasound

EXPERIMENTAL

Hybrid IVUS-OCT and control IVUS were performed after stenting

Diagnostic Test: Intravascular ultrasound

Optical coherence tomography

EXPERIMENTAL

Hybrid IVUS-OCT and control OCT were performed after stenting

Diagnostic Test: Optical coherence tomography

Interventions

Intravascular ultrasound DIAGNOSTIC_TEST

Hybrid IVUS-OCT and control IVUS were performed after stenting

Intravascular ultrasound

Optical coherence tomography DIAGNOSTIC_TEST

Hybrid IVUS-OCT and control OCT were performed after stenting

Optical coherence tomography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Patients eligible for elective percutaneous coronary intervention
• Understand and voluntarily sign the informed consent form

You may not qualify if:

• More than 1 stent was planned to deploy in culprit lesion
• In-stent restenosis
• Bifurcation lesion with proposed double stent implantation
• The length of the reference vessel segment proximal or distal to the lesion was less than 5mm
• The length of the implanted stent was larger than 33mm
• The diameter of reference vessel was less than 2 mm or larger than 4 mm
• Lesions were in left main or ostium of right coronary artery
• The distance between either end of the lesion and the lateral branches larger than 2 mm in diameter was less than 5 mm
• Angiography revealed thrombosis in culprit vessel
• Severely calcified lesions or tortuous coronary arteries
• Decreased blood flow (thrombolysis in myocardial infarction score ≤ 2)
• Breastfeeding or pregnant women, the subject (or his partner) who had a pregnancy plan during the trial or within 6 months after the end of the trial, and subject who did not agree to use contraception during the trial
• Participants who had withdrawn from other clinical studies within 3 months or are participating in other clinical trials
• Acute myocardial infarction occurred within one week prior to screening
• Cardiac troponin I or cardiac troponin T levels exceed the upper limit of normal reference values within 72 hours of procedure and were of clinical significance

Sponsors & Collaborators

• Harbin Medical University: lead
• Second Hospital of Jilin University: collaborator
• Wuhan Asia Heart Hospital: collaborator
• Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.: collaborator

Study Sites (3)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430010, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 150056, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ultrasonography, Interventional; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Tomography, Optical; Optical Imaging; Tomography; Investigative Techniques

Study Officials

• Bo Yu, MD, PhD

  The Second Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

• Bin Liu, MD, PhD

  Second Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Xi Su, MD, PhD

  Wuhan Asia Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cardiology

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 27, 2022
• Study Start: November 20, 2019
• Primary Completion: August 12, 2020
• Study Completion: July 30, 2021
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)