Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2025-07-01
Last updated
2026-04-16
Condition(s) studied
In-Stent RestenosisCoronary Artery Disease
Investigational drug(s) / intervention(s)
No intervention
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Presence of angiographic in-stent restenosis in the retrospective cross-sectional cohort — 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.
Occurrence of angiographic in-stent restenosis in the prospective cohort — 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.
Target lesion revascularization in the prospective cohort — Within 12 months after index PCI Target lesion revascularization related to prior stent restenosis requiring repeat PCI or CABG.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Zhejiang
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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