Balloon Treatment Versus Stents for Heart Artery Narrowing in Diabetes
Compares a drug-coated balloon with a standard stent in adults with heart disease and diabetes.
Plain-language title generated from the registry record
Registry title: DCB for CAD With Type 2 Diabetes
Key facts
- Where
- Kaifeng, Luoyang, Ningbo, Shanghai, Yibin, and Zhengzhou, ChinaSee the 6 sites
Where in China
- Huaihe Hospital of Henan UniversityKaifeng, ChinaNo longer taking part
- Luoyang Central Hospital Affiliated to Zhengzhou UniversityLuoyang, ChinaNo longer taking part
- Ninghai First HospitalNingbo, ChinaNo longer taking part
- Shanghai Tenth People's HospitalShanghai, ChinaNo longer taking part
- The Second People's Hospital of YibinYibin, ChinaNo longer taking part
- The First Affiliated Hospital of Zhengzhou UninversityZhengzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai 10th People's Hospital
- Trial code
- NCT07009938
- Record updated
- 8 June 2025
- Original description
Patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often present with diffuse, complex lesions and a higher risk of in-stent restenosis after PCI. While drug-eluting stents (DES) remain the standard treatment, their long-term efficacy in diabetic patients is suboptimal. Drug-coated balloons (DCBs) offer a "leave nothing behind" strategy by delivering anti-proliferative drugs without permanent implants, potentially reducing restenosis and adverse events. Although DCBs have shown promise in selected lesion types, evidence in T2DM patients is limited, particularly from prospective, randomized trials. This study aims to evaluate the efficacy and safety of DCB angioplasty compared to conventional strategies in patients with CAD and T2DM, focusing on angiographic outcomes, symptom relief, and major adverse cardiovascular events.Read full original descriptionShow less
Long-Term Efficacy and Safety of Drug-Coated Balloon Angioplasty in Patients With Coronary Artery Disease and Type 2 Diabetes: A Multicenter, Prospective, Randomized Controlled Trial
Patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often present with diffuse, complex lesions and a higher risk of in-stent restenosis after PCI. While drug-eluting stents (DES) remain the standard treatment, their long-term efficacy in diabetic patients is suboptimal. Drug-coated balloons (DCBs) offer a "leave nothing behind" strategy by delivering anti-proliferative drugs without permanent implants, potentially reducing restenosis and adverse events. Although DCBs have shown promise in selected lesion types, evidence in T2DM patients is limited, particularly from prospective, randomized trials. This study aims to evaluate the efficacy and safety of DCB angioplasty compared to conventional strategies in patients with CAD and T2DM, focusing on angiographic outcomes, symptom relief, and major adverse cardiovascular events.
Inclusion: Age ≥18 years; Diagnosed CAD with ≥70% stenosis in ≥1 coronary artery confirmed by coronary angiography; Diagnosed type 2 diabetes (per WHO criteria); Target lesion suitable for DCB (diameter 2.0-4.0 mm, length ≤40 mm); Informed consent provided.
Exclusion: Prior coronary artery bypass surgery or PCI with complications; Active bleeding or uncontrolled anticoagulation; Allergy to DCB components; Psychiatric conditions limiting compliance; STEMI within 24 hours; Severe hepatic/renal dysfunction; Pregnancy or lactation.