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DCB for CAD With Type 2 Diabetes
Sponsor: Shanghai 10th People's Hospital
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-07-01
Completion Date
2028-07-01
Last Updated
2025-06-08
Healthy Volunteers
No
Conditions
Interventions
Drug-Coated Balloon (DCB)
Following lesion preparation (usually with a standard balloon), a drug-coated balloon is advanced to the target lesion. The balloon is inflated and maintained to allow effective drug transfer to the vessel wall.
Drug-Eluting Stent (DES) implantation
After coronary angiography identifies the target lesion, a DES is selected based on the vessel size. Post-deployment angiography is performed to confirm the result and check for complications.
Locations (6)
Huaihe Hospital of Henan University
Kaifeng, Henan, China
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou Uninversity
Zhengzhou, Henan, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
Ninghai First Hospital
Ningbo, Zhejiang, China