Active — Not RecruitingNot Applicable

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

China3,600 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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)

What they're measuring

Presence of angiographic in-stent restenosis in the retrospective cross-sectional cohort

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

Occurrence of angiographic in-stent restenosis in the prospective cohort

Timeframe: At follow-up coronary angiography, up to 12 months after index PCI

Target lesion revascularization in the prospective cohort

Timeframe: Within 12 months after index PCI

Trial details

NCT IDNCT07533656

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-07-01

View on ClinicalTrials.gov More In-Stent Restenosis trials