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PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

Primary Purpose

Coronary Artery Disease, Intravascular Imaging Device

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intravascular ultrasound
Optical coherence tomography
Sponsored by
Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Hybrid imaging, Intravascular ultrasound, Optical coherence tomography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 larger than 2 mm or less 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  • Participants who had withdrawn from other clinical studies within 3 months or are participating in other clinical trials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

Sites / Locations

  • The Second Affiliated Hospital of Harbin Medical University
  • Wuhan Asia Heart Hospital
  • The Second Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intravascular ultrasound

Optical coherence tomography

Arm Description

Hybrid IVUS-OCT and control IVUS were performed after stenting

Hybrid IVUS-OCT and control OCT were performed after stenting

Outcomes

Primary Outcome Measures

Clear stent capture rate (CSCR)
The CSCR detected was defined as the ratio of the clear stent length to the total stent length

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2022
Last Updated
February 10, 2023
Sponsor
Harbin Medical University
Collaborators
Second Hospital of Jilin University, Wuhan Asia Heart Hospital, Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05596279
Brief Title
PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System
Official Title
Clinical Performance of a Novel Hybrid Intravascular Ultrasound-Optical Coherence Tomography System: a Prospective Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University
Collaborators
Second Hospital of Jilin University, Wuhan Asia Heart Hospital, Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Intravascular Imaging Device
Keywords
Hybrid imaging, Intravascular ultrasound, Optical coherence tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravascular ultrasound
Arm Type
Experimental
Arm Description
Hybrid IVUS-OCT and control IVUS were performed after stenting
Arm Title
Optical coherence tomography
Arm Type
Experimental
Arm Description
Hybrid IVUS-OCT and control OCT were performed after stenting
Intervention Type
Diagnostic Test
Intervention Name(s)
Intravascular ultrasound
Intervention Description
Hybrid IVUS-OCT and control IVUS were performed after stenting
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical coherence tomography
Intervention Description
Hybrid IVUS-OCT and control OCT were performed after stenting
Primary Outcome Measure Information:
Title
Clear stent capture rate (CSCR)
Description
The CSCR detected was defined as the ratio of the clear stent length to the total stent length
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Proportion of patients with clear image length ≥ 24mm
Description
Measured by IVUS, OCT and hybrid IVUS-OCT
Time Frame
During the procedure
Title
Detection rate of edge dissection, tissue prolapse and stent malapposition
Description
Assessed by IVUS, OCT and hybrid IVUS-OCT
Time Frame
During the procedure
Title
Device success rate
Description
Device success is defined as well-manipulated and capable of acquiring intravascular images
Time Frame
During the procedure
Title
Adverse procedure-related adverse cardiovascular events
Description
Coronary spasm, acute vessel occlusion, coronary dissection, or thrombosis
Time Frame
Periprocedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yu, MD, PhD
Organizational Affiliation
The Second Affiliated Hospital of Harbin Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bin Liu, MD, PhD
Organizational Affiliation
Second Hospital of Jilin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xi Su, MD, PhD
Organizational Affiliation
Wuhan Asia Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430010
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
150056
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

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