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

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 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: This observational study will recruit patients with known coronary artery disease who are scheduled for repeat coronary angiography at Beijing Anzhen Hospital, Capital Medical University. Eligible participants are adults aged 18 to 80 years with full decision-making capacity, who have a prior angiographic diagnosis of coronary artery disease (defined as ≥ 50% diameter stenosis in at least one coronary artery) and are indicated for a follow-up coronary angiography procedure. All enrolled participants must provide written informed consent before study participation. Patients will be excluded from the study if they undergo coronary artery bypass grafting during the index hospitalization, have angiographic images of insufficient quality to perform quantitative coronary angiography (QCA) or Angio FFR analysis, or present with severe concomitant valvular heart disease, cardiomyopathy, or active infection.

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Coronary Artery Disease (CAD)

Being tested

Progression of non-target vessels

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.

• Progression of non-target vesselsOther

  Drug-eluting stents (DES) have markedly reduced the risks of target lesion restenosis and repeat revascularization [2]. Nevertheless, the progression of coronary atherosclerosis does not cease after percutaneous coronary intervention (PCI). Clinical evidence demonstrates that even after successful target lesion revascularization and adherence to standardized secondary prevention therapy, patients may still develop progression of non-target lesions (NTLs) during follow-up, which further leads to non-target vessel revascularization, recurrent myocardial infarction, and major adverse cardiovascular events (MACE) [3].

  This finding indicates that post-PCI risk is not solely driven by severely stenotic target lesions; to a certain extent, it may also arise from initially untreated non-target lesions that harbor progression potential. This issue has become one of the key factors limiting the long-term clinical benefit of patients with coronary artery disease following interventional therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Angiographic Progression of Non-Target Lesions

   Quantitative coronary angiography (QCA) will be performed to compare coronary angiographic images obtained at baseline (during the initial percutaneous coronary intervention) and during follow-up. All non-target coronary segments that did not receive initial interventional treatment will be quantitatively measured for luminal diameter stenosis to assess the progression of atherosclerotic lesions.

   Non-target lesion progression is defined as meeting any of the following criteria: an absolute increase of ≥20% in luminal diameter stenosis in the same non-target segment at follow-up angiography compared with baseline; progression from baseline diameter stenosis <50% to clinically significant stenosis with diameter stenosis ≥50%; or new-onset atherosclerotic lesions with diameter stenosis ≥50% in non-target segments during follow-up.

   Based on this endpoint, clinical, inflammatory and metabolic risk factors associated with non-target lesion progression will be analyzed, and the incidence of

   Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Aug 2026
2. Study start1 Jan 2020
3. Primary completion1 Aug 2026 (estimated)
4. Study completion31 Dec 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
• More trials run by Beijing Anzhen HospitalThe 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.