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

NCT07533656 | Active Not Recruiting

• 2 other identifiers: 2025-14682025C02145
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

In-Stent Restenosis; Coronary Artery Disease

Keywords

Vertical Auto Profile; VAP; Lipid subfractions; Percutaneous Coronary Intervention; Lipoprotein(a); Remnant lipoproteins

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Multiple-lesion in-stent restenosis in the retrospective cross-sectional cohort

  At repeat coronary angiography, more than 6 month after prior PCI

• Multivessel in-stent restenosis in the retrospective cross-sectional cohort

  At repeat coronary angiography, more than 6 month after prior PCI

• ISR-related major adverse cardiovascular events in the prospective cohort

  Within 12 months after index PCI

Study Arms (2)

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

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

Interventions

No intervention OTHER

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; Retrospective Cross-sectional Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 16, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)