PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05596279
• Other study ID #: VP-3003-1901
• Status: Completed
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2023
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 30, 2021
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Intravascular ultrasound
Hybrid IVUS-OCT and control IVUS were performed after stenting
• Optical coherence tomography
Hybrid IVUS-OCT and control OCT were performed after stenting

Locations

Country	Name	City	State
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Wuhan Asia Heart Hospital	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Harbin Medical University	Panorama Hengsheng (Beijing) Science and Technology Co., Ltd., Second Hospital of Jilin University, Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome

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