IVUS CHIP China Registry

Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures China Registry

The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI.

Study Overview

• Status: Recruiting
• Conditions: Complex Higher Risk Indicated Patients Undergoing PCI
• Intervention / Treatment: Device: The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific

• Study Type: Observational
• Enrollment (Estimated): 2020

Contacts and Locations

• Study Contact: Name: Chenguang Li, Doctor; Phone Number: 86+ 13816767665; Email: li.chenguang@zs-hospital.sh.cn
• Study Contact Backup: Name: Junbo Ge, Doctor; Email: jbge@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan Zhongshan Hospital
    • Contact: Chenguang Li, Doctor; Email: li.chenguang@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

IVUS-guided approach in patients with complex coronary lesions undergoing PCI

Description

Inclusion Criteria:

1. The patient must be ≥18 years of age

2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:

   1. Angiographic heavy calcification
   2. Ostial lesions
   3. True bifurcation lesions involving side-branches >2.5mm
   4. Left main lesions
   5. Chronic total occlusion
   6. In-stent restenosis
   7. Long-lesions (estimated stent length > 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
4. All lesions must be suitable for treatment with 2nd generation drug eluting stents (or drug-coated balloons when indicated, e.g., in-stent restenosis, branching of bifurcation lesions)
5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee

Exclusion Criteria:

1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
2. Known untreated severe valvular heart disease
3. Requiring PCI in a diseased aorto-coronary bypass
4. Known contraindication or hypersensitivity to anticoagulants
5. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
6. Non-cardiac co-morbidities with a life expectancy less than 1 year
7. Currently participating in a clinical trial that is not yet at its primary endpoint. The patient is not allowed to participate in an investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
8. Women who are pregnant or who are breastfeeding
9. Subject's circumstances that will not allow appropriate consenting procedures or follow-up activities (per investigator's discretion)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints.	Target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction*, or clinically indicated target-vessel revascularization at 1 year. It means the time of the patient's occurrence of any of the three events in one year.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-first-event analysis will be primarily used for clinical endpoints.	The time of the first event of Composite of target-vessel myocardial infarction* and clinically indicated target vessel revascularization; The time of the first event of Clinically-indicated target vessel revascularization; The time of the first event of Composite of cardiac death and target-vessel myocardial infarction*; The time of the first event of Target-Lesion Failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction*, or clinically indicated target-lesion revascularization; The time of the first event of Target-lesion revascularization; The time of Cardiac death	full-time process until 2 Year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IVUS CHIP China Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Currently,All data of projects will be shared with sponsors and leading site principal investigators. Other site investigators are undecided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No