PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

Clinical Performance of a Novel Hybrid Intravascular Ultrasound-Optical Coherence Tomography System: a Prospective Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Intravascular Imaging Device
• Intervention / Treatment: Diagnostic test: Intravascular ultrasound; Diagnostic test: Optical coherence tomography

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • The Second Affiliated Hospital of Harbin Medical University
  • Hubei
    • Wuhan, Hubei, China, 430010
      • Wuhan Asia Heart Hospital
  • Jilin
    • Changchun, Jilin, China, 150056
      • The Second Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion criteria:

• 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)

Patients-level exclusion criteria:

• 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
• Renal insufficiency with creatinine > 200μmol/L
• Unsuitable for coronary artery bypass grafting (CABG)
• Unsuitable for percutaneous coronary intervention;
• Coronary spasm
• Chronic total occlusion or subtotal occlusion
• Severe hemodynamic disturbances or shock
• History of CABG
• Coagulation is abnormal and clinically significant
• Severe heart failure (NYHA III, IV or Left ventricular ejection fraction < 30%)
• History of contrast allergy
• Multi-vessel disease
• Chemotherapy or planned chemotherapy
• Investigators consider unsuitable for participants selected for this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intravascular ultrasound; Hybrid IVUS-OCT and control IVUS were performed after stenting	Diagnostic test: Intravascular ultrasound; Hybrid IVUS-OCT and control IVUS were performed after stenting
EXPERIMENTAL: Optical coherence tomography; Hybrid IVUS-OCT and control OCT were performed after stenting	Diagnostic test: Optical coherence tomography; Hybrid IVUS-OCT and control OCT were performed after stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with clear image length ≥ 24mm	Measured by IVUS, OCT and hybrid IVUS-OCT	During the procedure
Detection rate of edge dissection, tissue prolapse and stent malapposition	Assessed by IVUS, OCT and hybrid IVUS-OCT	During the procedure
Device success rate	Device success is defined as well-manipulated and capable of acquiring intravascular images	During the procedure
Adverse procedure-related adverse cardiovascular events	Coronary spasm, acute vessel occlusion, coronary dissection, or thrombosis	Periprocedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2019
• Primary Completion (ACTUAL): August 12, 2020
• Study Completion (ACTUAL): July 30, 2021

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (ACTUAL): October 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Hybrid imaging; Intravascular ultrasound
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: VP-3003-1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No