PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System

NCT ID: NCT05596279

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2021-07-30

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.

Conditions

Coronary Artery Disease; Intravascular Imaging Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intravascular ultrasound

Hybrid IVUS-OCT and control IVUS were performed after stenting

Group Type: EXPERIMENTAL

Intravascular ultrasound

Intervention Type: DIAGNOSTIC_TEST

Hybrid IVUS-OCT and control IVUS were performed after stenting

Optical coherence tomography

Hybrid IVUS-OCT and control OCT were performed after stenting

Group Type: EXPERIMENTAL

Optical coherence tomography

Intervention Type: DIAGNOSTIC_TEST

Hybrid IVUS-OCT and control OCT were performed after stenting

Interventions

Intravascular ultrasound

Hybrid IVUS-OCT and control IVUS were performed after stenting

Intervention Type: DIAGNOSTIC_TEST

Optical coherence tomography

Hybrid IVUS-OCT and control OCT were performed after stenting

Intervention Type: DIAGNOSTIC_TEST

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

• 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)

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role: collaborator

Panorama Hengsheng (Beijing) Science and Technology Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yu Bo

Director of Department of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Yu, MD, PhD

Role: STUDY_CHAIR

The Second Affiliated Hospital of Harbin Medical University

Bin Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Hospital of Jilin University

Xi Su, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wuhan Asia Heart Hospital

Locations

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

VP-3003-1901

Identifier Type: -

Identifier Source: org_study_id