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

NCT07748754 | Active Not Recruiting

• 1 other identifier: KS2026071
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Artery Disease (CAD)

Outcome Measures

Primary Outcomes (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

  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

Study Arms (1)

Progression group、Non-progression group

Other: Progression of non-target vessels

Interventions

Progression of non-target vessels OTHER

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.

Progression group、Non-progression group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• To be eligible for enrollment in this study, participants must meet all of the following criteria:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

BeijingAnzhen Hospital

Beijing, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: August 6, 2026
• Study Start: January 1, 2020
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

CN (1)