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A Prospective Cohort Study on the Use of Domestic Coronary Drug-Eluting Balloons in Patients with Coronary Artery Disease

A Prospective Cohort Study on the Use of Domestic Coronary Drug-Eluting Balloons in Patients with Coronary Artery Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111849
Enrollment
Unknown
Registered
2025-11-06
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Coronary Artery Disease

Interventions

Sponsors

General Hospital of Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: General Inclusion Criteria: 1.Age between 18 and 80 years; 2.Diagnosed with coronary artery disease (CAD) and eligible for percutaneous coronary intervention (PCI); 3.Patient agrees to participate in the study and signs the informed consent form. Angiographic Inclusion Criteria: 1.No more than two vessels requiring treatment; 2.No more than one primary small vessel lesion (reference vessel diameter <= 2.75 mm) requiring treatment; 3.Successful target lesion predilatation, without dissection of type C or higher, no tear or other complications, and TIMI grade 3 flow achieved.

Exclusion criteria

Exclusion criteria: 1.Patients with severe heart failure: left ventricular ejection fraction (LVEF) < 35% or New York Heart Association (NYHA) class IV; 2.Hemodynamically unstable patients: Killip class III or IV; 3.Severe anemia: hemoglobin < 60 g/L; 4.Platelet count < 100 × 10^9/L; 5.Concomitant intracranial hemorrhage within 1 month, major organ bleeding, or recent surgery for gastrointestinal tumors; 6.Pregnant patients; 7.Patients with other contraindications to coronary intervention; 8.Patients with poor compliance as judged by the investigator, making follow-up difficult.

Design outcomes

Primary

MeasureTime frame
Incidence of target lesion failure (TLF) at 1 year post-procedure;

Secondary

MeasureTime frame
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 1 year post-procedure, defined as a composite of all-cause death, myocardial infarction (MI), ischemic stroke, and target vessel revascularization (TVR), as well as each individual component event;Incidence of bleeding events at 1 year post-procedure according to BARC criteria;

Countries

China

Contacts

Public ContactXiaozeng Wang

No. 83 Wenhua Road, Shenhe District, Shenyang, Liaoning Province, China, General Hospital of Northern Theater Command

wxiaozeng@163.com+86 133 0988 5930

Outcome results

None listed

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