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

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: Active, not recruiting
• Conditions: Coronary Artery Disease; In-Stent Restenosis
• Intervention / Treatment: Other: No intervention

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: Observational
• Enrollment (Estimated): 3600

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Presence of angiographic in-stent restenosis in the retrospective cross-sectional cohort	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	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	Target lesion revascularization related to prior stent restenosis requiring repeat PCI or CABG.	Within 12 months after index PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple-lesion in-stent restenosis in the retrospective cross-sectional cohort	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	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	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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Lipoprotein(a); VAP; Vertical Auto Profile; Lipid subfractions; Remnant lipoproteins
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID 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