Coronary Artery DiseaseNCT05596279
PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System
A study testing Intravascular ultrasound and Optical coherence tomography in people with Coronary Artery Disease and Intravascular Imaging Device, run by Harbin Medical University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Intravascular Imaging Device
- What is being tested?
- Intravascular ultrasound and Optical coherence tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 20 Nov 2019to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Patients eligible for elective percutaneous coronary intervention
- Understand and voluntarily sign the informed consent form
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Second Hospital of Jilin University
Changchun, Jilin, 150056
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430010
About this study
Official title: 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.
- Being tested
- Intravascular ultrasound, Optical coherence tomography
- Keywords
- Hybrid imaging, Intravascular ultrasound, Optical coherence tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular ultrasoundDiagnostic test
Hybrid IVUS-OCT and control IVUS were performed after stenting
Optical coherence tomographyDiagnostic test
Hybrid IVUS-OCT and control OCT were performed after stenting
| Study group | Role | What they receive |
|---|---|---|
| Intravascular ultrasound | Experimental | Hybrid IVUS-OCT and control IVUS were performed after stenting Receives: Diagnostic Test: Intravascular ultrasound |
| Optical coherence tomography | Experimental | Hybrid IVUS-OCT and control OCT were performed after stenting Receives: Diagnostic Test: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clear stent capture rate (CSCR)
The CSCR detected was defined as the ratio of the clear stent length to the total stent length
Measured: During the procedure
Secondary outcomes (4)
Proportion of patients with clear image length ≥ 24mm
Measured by IVUS, OCT and hybrid IVUS-OCT
Measured: During the procedure
Detection rate of edge dissection, tissue prolapse and stent malapposition
Assessed by IVUS, OCT and hybrid IVUS-OCT
Measured: During the procedure
Device success rate
Device success is defined as well-manipulated and capable of acquiring intravascular images
Measured: During the procedure
Adverse procedure-related adverse cardiovascular events
Coronary spasm, acute vessel occlusion, coronary dissection, or thrombosis
Measured: Periprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start20 Nov 2019
- Primary completion12 Aug 2020
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Hospital of Jilin University, Wuhan Asia Heart Hospital, Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.
- Responsible party
- Principal investigator, Yu Bo, The Second Affiliated Hospital of Harbin Medical University
- Investigators
- Bo Yu, MD, PhD, Study chair, The Second Affiliated Hospital of Harbin Medical UniversityBin Liu, MD, PhD, Principal investigator, Second Hospital of Jilin UniversityXi Su, MD, PhD, Principal investigator, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596279
- Sponsor's protocol ID
- VP-3003-1901
- Status last verified
- Feb 2023
- First submitted
- 20 Oct 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Novel Hybrid Intravascular Ultrasound-Optical Coherence Tomography System: a Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05596279
- Acronym / sponsor ID
- VP-3003-1901
- Keywords
- Hybrid imaging, Intravascular ultrasound, Optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Second Hospital of Jilin University, Wuhan Asia Heart Hospital, Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravascular ultrasound | Experimental | Diagnostic Test: Intravascular ultrasoundHybrid IVUS-OCT and control IVUS were performed after stenting |
| Optical coherence tomography | Experimental | Diagnostic Test: Optical coherence tomographyHybrid IVUS-OCT and control OCT were performed after stenting |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years
- Patients eligible for elective percutaneous coronary intervention
- Understand and voluntarily sign the informed consent form
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular ultrasoundHybrid IVUS-OCT and control IVUS were performed after stenting | Diagnostic test | Intravascular ultrasound |
| Optical coherence tomographyHybrid IVUS-OCT and control OCT were performed after stenting | Diagnostic test | Optical coherence tomography |
Primary outcome
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
4 secondary outcomes
Proportion of patients with clear image length ≥ 24mm
Time frame: During the procedure
Detection rate of edge dissection, tissue prolapse and stent malapposition
Time frame: During the procedure
Device success rate
Time frame: During the procedure
Adverse procedure-related adverse cardiovascular events
Time frame: Periprocedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Yu, MD, PhD study chair
The Second Affiliated Hospital of Harbin Medical University
Bin Liu, MD, PhD principal investigator
Second Hospital of Jilin University
Xi Su, MD, PhD principal investigator
Wuhan Asia Heart Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular ultrasound and Optical coherence tomography in people with Coronary Artery Disease and Intravascular Imaging Device, run by Harbin Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clear stent capture rate (CSCR) (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.