In-Stent RestenosisNCT07533656
VAP-Measured Lipid Subfractions and In-Stent Restenosis After PCI
An observational study of In-Stent Restenosis and Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-Stent Restenosis, Coronary Artery Disease
- How many people
- 3,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: 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.
Read the 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.
- Conditions
- In-Stent Restenosis, Coronary Artery Disease
- Being tested
- No intervention
- Keywords
- Vertical Auto Profile, VAP, Lipid subfractions, Percutaneous Coronary Intervention, Lipoprotein(a), Remnant lipoproteins
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Within 12 months after index PCI
Secondary outcomes (3)
Multiple-lesion in-stent restenosis in the retrospective cross-sectional cohort
Defined as in-stent restenosis involving >=2 lesions.
Measured: 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.
Measured: 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.
Measured: Within 12 months after index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jul 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-Stent RestenosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533656
- Sponsor's protocol ID
- 2025-1468
- Other IDs
- 2025C02145
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Cohort Study of VAP-Measured Lipid and Lipoprotein Subfractions and In-Stent Restenosis After Percutaneous Coronary Intervention Across ASCVD Risk Strata
- ClinicalTrials.gov ID
- NCT07533656
- Acronym / sponsor ID
- 2025-1468
- Conditions
- In-Stent Restenosis, Coronary Artery Disease
- Keywords
- Vertical Auto Profile, VAP, Lipid subfractions, Percutaneous Coronary Intervention, Lipoprotein(a), Remnant lipoproteins
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cross-sectional Cohort | – | Other: No interventionAdults 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. |
| Prospective Follow-up Cohort | – | Other: No interventionAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study only. Participants receive standard clinical care. Serum samples from routine clinical blood collection are used for VAP testing without additional study-specific intervention. | Other | Prospective Follow-up Cohort, Retrospective Cross-sectional Cohort |
Primary outcome
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.
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.
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.
3 secondary outcomes
Multiple-lesion in-stent restenosis in the retrospective cross-sectional cohort
Time frame: 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
ISR-related major adverse cardiovascular events in the prospective cohort
Time frame: Within 12 months after index PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-Stent Restenosis and Coronary Artery Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.