Clinical trial NCT05596279: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Intravascular Imaging Device
Keywords: Hybrid imaging
Intravascular ultrasound
Optical coherence tomography
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Second Hospital of Jilin University
name: Wuhan Asia Heart Hospital
name: Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.
First posted: 2022-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Clear stent capture rate (CSCR)
timeFrame: During the procedure
Secondary outcomes:
measure: Proportion of patients with clear image length ≥ 24mm
timeFrame: During the procedure
measure: Detection rate of edge dissection, tissue prolapse and stent malapposition
timeFrame: During the procedure
measure: Device success rate
timeFrame: During the procedure
measure: Adverse procedure-related adverse cardiovascular events
timeFrame: Periprocedure
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu, MD, PhD
role: STUDY_CHAIR
affiliation: Second Hospital of Jilin University
name: Bin Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Asia Heart Hospital
name: Xi Su, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: