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A Prospective Clinical Study on the Safety and Efficacy of Drug-Coated Balloon Treatment for Large Coronary Arteries Guided by Intravascular Imaging

A Prospective Clinical Study on the Safety and Efficacy of Drug-Coated Balloon Treatment for Large Coronary Arteries Guided by Intravascular Imaging

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108347
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-09-05
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-ST-segment elevation acute coronary syndrome (NSTEACS) or chronic coronary syndrome (CCS)

Interventions

observation group:None

Sponsors

Beijing Luhe Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Clinical inclusion criteria 1. Age>= 18 years old, <= 80 years old, male or female subjects 2. Patients with clinical diagnosis of NSTEACS or (CCS) and requiring PCI treatment 3. Agree to participate in this study, and the family members sign the informed consent form 4. Agree to receive 6 months of interventional follow-up 5. Agree to receive clinical follow-up for 12 months, 24 months, and 60 months after surgery 6. Patients can understand the purpose of the study psychologically and linguistically and fully comply with the research plan Imaging and functional inclusion criteria 1. De novo target lesion 2. Reference vessel diameter = 3mm 3. Non-complicated coronary artery lesions (1) The number of each vascular lesion planned to be treated < 3, the planned implantation of drug-eluting stent (DES)/drug-coated balloon (DCB) < 3, or the total length of DES/DCB planned to be implanted <= 60mm (2) Bifurcation lesions do not require 2 DES/DCBs (3) Non-left main lesion (4) Non-venous or arterial graft lesions (5) Non-chronic total occlusive lesions (6) There is no need to use rotary grinding and other devices

Exclusion criteria

Exclusion criteria: 1. Patients with heart failure 2. Patients with concomitant cardiogenic shock 3. Patients with severe valvular heart disease 4. Prior CABG 5. Women who are pregnant or breastfeeding 6. Patients with life expectancy = 1 year or who may have difficulties in clinical follow-up 7. Those at high risk for bleeding or in whom anticoagulant or antiplatelet agents are contraindicated 8. Patients without access to contrast media 9. Patients with concomitant atrial fibrillation requiring anticoagulation 10. Patients with stroke within 6 months before surgery 11. Patients enrolled in any other clinical trial 12. Patients who are ineligible for angiography because of current or past severe renal failure (GFR<30ml/min) 13. Severe hepatic insufficiency 14. Heart transplant recipients 15. Patients deemed by the investigators to be ineligible for enrollment for other reasons 16. Intolerance to aspirin, clopidogrel, and/or ticagrelor 17. History of peptic ulcer or gastrointestinal bleeding within the past 6 months 18. Lesions for which high-quality transluminal imaging is not available

Design outcomes

Primary

MeasureTime frame
Device-oriented composite endpoints;Patient-oriented composite endpoint;Definite/possible stent thrombosis;Bleeding Academic Research Consortium type 3-5 bleeding;

Countries

China

Contacts

Public ContactGuangyao Zhai

Beijing Luhe Hospital, Capital Medical University

drzhaiguangyao@163.com+86 185 0130 8666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026