VAP-Measured Lipid Subfractions and In-Stent Restenosis After PCI

April 9, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Multicenter Observational Cohort Study of VAP-Measured Lipid and Lipoprotein Subfractions and In-Stent Restenosis After Percutaneous Coronary Intervention Across ASCVD Risk Strata

This multicenter observational study investigates whether lipid and lipoprotein subfractions measured by Vertical Auto Profile (VAP) are associated with coronary in-stent restenosis after percutaneous coronary intervention (PCI). The study includes a retrospective cross-sectional component in patients with prior PCI who undergo repeat coronary angiography and a prospective follow-up component in patients undergoing index PCI. Serum samples obtained from routine clinical blood collection will be used for VAP testing without additional blood draws.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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.

Detailed Description

This is a multicenter observational cohort study designed to evaluate the association between VAP-measured lipid and lipoprotein subfractions and in-stent restenosis (ISR) after PCI across ASCVD risk strata.

The study includes two components.

Retrospective cross-sectional component:

Adults aged 18 years or older with prior successful implantation of second-generation drug-eluting stents who undergo repeat coronary angiography at participating centers will be screened. Eligible participants must have complete clinical data for ASCVD risk assessment, available stored serum samples for VAP testing, and angiographic data sufficient to determine ISR status. ISR is defined as >=50% stenosis in the stent-related lumen at repeat coronary angiography. Secondary outcomes in this component include multiple-lesion ISR and multivessel ISR.

Prospective follow-up component:

Adults aged 18 years or older undergoing index PCI at participating centers will be enrolled prospectively. Eligible participants must have complete clinical data for ASCVD risk assessment, serum samples available from routine clinical blood collection, and written informed consent when required by the local ethics committee. Participants will be followed until repeat coronary angiography or ISR-related clinical events. The primary outcome is angiographic ISR, defined as >=50% stenosis in the stent-related lumen at follow-up angiography. Secondary outcomes include target lesion revascularization within 1 year and ISR-related major adverse cardiovascular events within 1 year, including cardiac death, target-vessel myocardial infarction, and target lesion revascularization.

VAP testing will assess lipid and lipoprotein subfractions, including LDL subfractions, IDL, VLDL, HDL subfractions, lipoprotein(a), and remnant lipoprotein particles. Serum samples are obtained from routine clinical blood collection and sample reuse, and no additional venipuncture is required for study participation.

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.
3600

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine

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

Adults with coronary artery disease/ASCVD undergoing prior PCI with repeat coronary angiography or undergoing index PCI at participating centers, with clinical data sufficient for ASCVD risk assessment and serum samples available for VAP-based lipid and lipoprotein subfraction testing.

Description

Inclusion Criteria:

Retrospective cross-sectional component:

  • Age >=18 years
  • Prior successful implantation of second-generation drug-eluting stents
  • Repeat coronary angiography available at a participating center
  • Complete data available for ASCVD risk assessment
  • Stored serum sample available for VAP testing
  • Angiographic data sufficient to determine ISR status

Prospective component:

  • Age >=18 years
  • Undergoing index PCI
  • Planned routine follow-up coronary angiography
  • Complete data available for ASCVD risk assessment
  • Serum sample available from routine clinical blood collection
  • Able to provide written informed consent and any required privacy authorization

Exclusion Criteria:

  • Severe hepatic dysfunction (ALT or AST >3 x ULN or Child-Pugh class C)
  • Prior CABG with angioplasty performed in a non-native vessel
  • In-stent restenosis occurring within 1 month after PCI
  • Expected survival <1 year (prospective component)

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Retrospective Cross-sectional Cohort
Adults aged 18 years or older with prior successful implantation of second-generation drug-eluting stents who undergo repeat coronary angiography, have complete data for ASCVD risk assessment, and have stored serum samples available for VAP testing.
Other: No intervention
Observational study only. Participants receive standard clinical care. Serum samples from routine clinical blood collection are used for VAP testing without additional study-specific intervention.
Prospective Follow-up Cohort
Adults aged 18 years or older undergoing index PCI who have complete data for ASCVD risk assessment, available serum samples from routine clinical blood collection, and prospective follow-up for repeat coronary angiography or ISR-related clinical outcomes.
Other: No intervention
Observational study only. Participants receive standard clinical care. Serum samples from routine clinical blood collection are used for VAP testing without additional study-specific intervention.

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
Presence of angiographic in-stent restenosis in the retrospective cross-sectional cohort
Time Frame: At repeat coronary angiography, more than 6 month after prior PCI
In-stent restenosis is defined as >=50% luminal stenosis in the stent-related lumen at repeat coronary angiography.
At repeat coronary angiography, more than 6 month after prior PCI
Occurrence of angiographic in-stent restenosis in the prospective cohort
Time Frame: At follow-up coronary angiography, up to 12 months after index PCI
In-stent restenosis is defined as >=50% luminal stenosis in the stent-related lumen at follow-up coronary angiography.
At follow-up coronary angiography, up to 12 months after index PCI
Target lesion revascularization in the prospective cohort
Time Frame: Within 12 months after index PCI
Target lesion revascularization related to prior stent restenosis requiring repeat PCI or CABG.
Within 12 months after index PCI

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
Multiple-lesion in-stent restenosis in the retrospective cross-sectional cohort
Time Frame: At repeat coronary angiography, more than 6 month after prior PCI
Defined as in-stent restenosis involving >=2 lesions.
At repeat coronary angiography, more than 6 month after prior PCI
Multivessel in-stent restenosis in the retrospective cross-sectional cohort
Time Frame: At repeat coronary angiography, more than 6 month after prior PCI
Defined as in-stent restenosis involving >=2 vessels.
At repeat coronary angiography, more than 6 month after prior PCI
ISR-related major adverse cardiovascular events in the prospective cohort
Time Frame: Within 12 months after index PCI
Composite of cardiac death, target-vessel myocardial infarction, and target lesion revascularization related to in-stent restenosis.
Within 12 months after index PCI

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.
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.
July 1, 2025

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, 2028

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.
December 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).
March 30, 2026

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.
April 9, 2026

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.
April 16, 2026

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 16, 2026

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 9, 2026

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.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2025-1468
  • 2025C02145 (Other Grant/Funding Number: Department of Science and Technology of Zhejiang Province)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Coronary Artery Disease

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings