## Protocol Section
### Identification Module
**NCT ID:** NCT05596279

**Brief Title:** 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

#### Organization Study ID Info
**ID:** VP-3003-1901
#### Organization
**Class:** OTHER
**Full Name:** Harbin Medical University
### Status Module
#### Completion Date
**Date:** 2021-07-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-13

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-08-12

**Type:** ACTUAL

#### Start Date
**Date:** 2019-11-20

**Type:** ACTUAL

**Status Verified Date:** 2023-02

#### Study First Post Date
**Date:** 2022-10-27
**Type:** ACTUAL
**Study First Submit Date:** 2022-10-20
**Study First Submit QC Date:** 2022-10-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Second Hospital of Jilin University

**Class:** OTHER

**Name:** Wuhan Asia Heart Hospital

**Class:** UNKNOWN

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

#### Lead Sponsor

**Class:** OTHER

**Name:** Harbin Medical University

#### Responsible Party

**Investigator Affiliation:** The Second Affiliated Hospital of Harbin Medical University

**Investigator Full Name:** Yu Bo

**Investigator Title:** Director of Department of Cardiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Coronary Artery Disease

- Intravascular Imaging Device

**Keywords:**

- Hybrid imaging

- Intravascular ultrasound

- Optical coherence tomography

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Hybrid IVUS-OCT and control IVUS were performed after stenting

**Intervention Names:**

- Diagnostic Test: Intravascular ultrasound

**Label:** Intravascular ultrasound

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Hybrid IVUS-OCT and control OCT were performed after stenting

**Intervention Names:**

- Diagnostic Test: Optical coherence tomography

**Label:** Optical coherence tomography

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intravascular ultrasound

**Description:** Hybrid IVUS-OCT and control IVUS were performed after stenting

**Name:** Intravascular ultrasound

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Optical coherence tomography

**Description:** Hybrid IVUS-OCT and control OCT were performed after stenting

**Name:** Optical coherence tomography

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** The CSCR detected was defined as the ratio of the clear stent length to the total stent length

**Measure:** Clear stent capture rate (CSCR)

**Time Frame:** During the procedure

#### Secondary Outcomes

**Description:** Measured by IVUS, OCT and hybrid IVUS-OCT

**Measure:** Proportion of patients with clear image length ≥ 24mm

**Time Frame:** During the procedure

**Description:** Assessed by IVUS, OCT and hybrid IVUS-OCT

**Measure:** Detection rate of edge dissection, tissue prolapse and stent malapposition

**Time Frame:** During the procedure

**Description:** Device success is defined as well-manipulated and capable of acquiring intravascular images

**Measure:** Device success rate

**Time Frame:** During the procedure

**Description:** Coronary spasm, acute vessel occlusion, coronary dissection, or thrombosis

**Measure:** Adverse procedure-related adverse cardiovascular events

**Time Frame:** Periprocedure

### Eligibility Module

**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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Harbin

**Country:** China

**Facility:** The Second Affiliated Hospital of Harbin Medical University

**State:** Heilongjiang

**Zip:** 150086

**Location 2:**

**City:** Wuhan

**Country:** China

**Facility:** Wuhan Asia Heart Hospital

**State:** Hubei

**Zip:** 430010

**Location 3:**

**City:** Changchun

**Country:** China

**Facility:** The Second Hospital of Jilin University

**State:** Jilin

**Zip:** 150056

#### Overall Officials

**Official 1:**

**Affiliation:** The Second Affiliated Hospital of Harbin Medical University

**Name:** Bo Yu, MD, PhD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Second Hospital of Jilin University

**Name:** Bin Liu, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Wuhan Asia Heart Hospital

**Name:** Xi Su, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

### Misc Info Module

- Version Holder: 2024-05-24
