Active — Not RecruitingNot Applicable

Study on Risk Factors and Prognostic Value of Non-target Lesion Progression in Patients With Coronary Artery Disease

China1,400 participantsStarted 2020-01-01

Plain-language summary

The goal of this observational study is to explore the risk factors and prognostic value of non-target coronary lesion progression in patients aged 18-80 years with established coronary artery disease who are scheduled for repeat coronary angiography. The main questions it aims to answer are: What clinical, inflammatory and metabolic factors are independently associated with the progression of untreated non-target lesions after percutaneous coronary intervention? Does the initial interventional strategy (drug-eluting stent vs. drug-coated balloon) influence the long-term progression of non-target coronary lesions and subsequent clinical outcomes? Researchers will compare participants treated with drug-eluting stents (DES) and those treated with drug-coated balloons (DCB) at their prior index procedure to see if different local interventional modalities lead to differences in non-target lesion progression and major adverse cardiovascular events during follow-up. Participants will: Undergo clinically indicated repeat coronary angiography, with offline quantitative coronary angiography (QCA) analysis of all coronary segments Provide baseline clinical data, medical history and blood samples for inflammatory and metabolic biomarker testing Complete 3 years of regular clinical follow-up to track lesion evolution and cardiovascular endpoints

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria To be eligible for enrollment in this study, participants must meet all of the following criteria: Aged 18 to 80 years, regardless of gender, with full decision-making capacity; Previously diagnosed with coronary artery disease (coronary artery diameter stenosis ≥ 50%) by coronary angiography, and scheduled to undergo repeat coronary angiography; Able to provide written informed consent. Exclusion Criteria Participants will be excluded from the study if they meet any of the following criteria: Undergoing coronary artery bypass grafting (CABG) during the index hospitalization; Poor angiographic image quality (vessel overlap, inadequate opacification) that precludes quantitative coronary angiography (QCA) or Angio FFR analysis; Concomitant severe valvular heart disease, cardiomyopathy, or active infection.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Angiographic Progression of Non-Target Lesions

Timeframe: From baseline interventional procedure to follow-up coronary angiography (median follow-up duration of approximately 12 to 24 months, subject to the timing of routine clinical follow-up angiography); lesion progression-related events will be continuously

Trial details

NCT IDNCT07748754

SponsorBeijing Anzhen Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-01

View on ClinicalTrials.gov More Coronary Artery Disease (CAD) trials