IVUS CHIP China Registry

April 25, 2024 updated by: Shanghai Zhongshan Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2020

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 1 Year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-to-first-event analysis will be primarily used for clinical endpoints.
Time Frame: full-time process until 2 Year
  1. The time of the first event of Composite of target-vessel myocardial infarction* and clinically indicated target vessel revascularization
  2. The time of the first event of Clinically-indicated target vessel revascularization
  3. The time of the first event of Composite of cardiac death and target-vessel myocardial infarction*
  4. 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
  5. The time of the first event of Target-lesion revascularization
  6. The time of Cardiac death
full-time process until 2 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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