PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Intravascular Imaging Device
• Interventions: Diagnostic Test: Intravascular ultrasound; Diagnostic Test: Optical coherence tomography

• Registration Number: NCT05596279
• Lead Sponsor: Harbin Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-20
• Primary Completion: 2020-08-12
• Study Completion: 2021-07-30
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravascular ultrasound	Intravascular ultrasound	Hybrid IVUS-OCT and control IVUS were performed after stenting
Optical coherence tomography	Optical coherence tomography	Hybrid IVUS-OCT and control OCT were performed after stenting

Primary Outcome Measures

Name	Time	Method
Clear stent capture rate (CSCR)	During the procedure	The CSCR detected was defined as the ratio of the clear stent length to the total stent length

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

The Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China