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Drug-Eluting Stents Combined with Drug-Coated Balloons for Diffuse Lesions in Native Coronary Arteries: A Prospective, Randomized Controlled Trial

Clinical Study of Drug-Eluting Stents Combined with Drug-Coated Balloons for Complex Lesions in Native Coronary Arteries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100411
Enrollment
Unknown
Registered
2025-04-09
Start date
2025-04-10
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

cardiovascular medicine

Interventions

Control Group:Drug-eluting stents (DES)
Intervention Group:Drug-eluting stents (DES) combined with drug-coated balloons (DCB)

Sponsors

Guidong People’s Hospital of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 25 to 80 years old; 2. Meet the diagnostic criteria for coronary atherosclerotic heart disease and be suitable for PCI treatment; 3. Coronary angiography confirms the presence of stenosis or occlusion of at least one major coronary artery of the three important coronary arteries. PCI segment lesion features are required; 4. Cardiac function grade Killip grade I~II, NYHA grade I~II or LVEF >40%; 5. Patients with chronic total occlusion lesions who can complete the opening of the occlusion segment; 6. Surgical tolerance; 7. Informed consent of patients and family members to the study.

Exclusion criteria

Exclusion criteria: 1. Severe heart failure (killip class III-IV); 2. Moderate to severe aortic stenosis, severe aortic regurgitation, dissecting aneurysm, severe pulmonary hypertension, and serious mechanical complications; 3. The target blood vessel is a chronic total occlusion lesion of the coronary artery, and fails to pass the guidewire and balloon; 4. There are various bleeding tendency diseases: such as peptic ulcers; 5. Those who have undergone PCI and are now restenosis in the stent; 6. Patients with severe arrhythmia; 7. Patients with malignant tumors, acute liver and kidney failure, severe respiratory diseases or infectious diseases; Those who are mentally abnormal or unable to cooperate with the completion of the trial; 8. Those who need to undergo other systematic surgeries in the near future; 9. Patients with contrast allergy.

Design outcomes

Primary

MeasureTime frame
Minimal Lumen Diameter;Degree of Stenosis;—

Secondary

MeasureTime frame
Cardiac function;Major Adverse Cardiovascular Events ;—

Countries

China

Contacts

Public ContactMeng Dongsheng

Guidong People’s Hospital of Guangxi Zhuang Autonomous Region

13977430120@163.com+86 139 7743 0120

Outcome results

None listed

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