PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

February 10, 2023 updated by: Yu Bo, Harbin Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clear stent capture rate (CSCR)
Time Frame: During the procedure
The CSCR detected was defined as the ratio of the clear stent length to the total stent length
During the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with clear image length ≥ 24mm
Time Frame: During the procedure
Measured by IVUS, OCT and hybrid IVUS-OCT
During the procedure
Detection rate of edge dissection, tissue prolapse and stent malapposition
Time Frame: During the procedure
Assessed by IVUS, OCT and hybrid IVUS-OCT
During the procedure
Device success rate
Time Frame: During the procedure
Device success is defined as well-manipulated and capable of acquiring intravascular images
During the procedure
Adverse procedure-related adverse cardiovascular events
Time Frame: Periprocedure
Coronary spasm, acute vessel occlusion, coronary dissection, or thrombosis
Periprocedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harbin Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wuhan Asia Heart Hospital
Second Hospital of Jilin University
Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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