DCB for CAD With Type 2 Diabetes
Launched by SHANGHAI 10TH PEOPLE'S HOSPITAL · Jun 6, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness and safety of a treatment called drug-coated balloons (DCBs) for patients with coronary artery disease (CAD) who also have type 2 diabetes. Patients with these conditions often face challenges because traditional treatments, like drug-eluting stents, may not work as well for them over time. DCBs work by delivering medication directly to the area needing treatment without leaving any permanent devices behind, which could help reduce the chances of complications like re-narrowing of the arteries. The trial will compare DCBs to standard treatments and will look at how well the treatment works, whether it helps relieve symptoms, and if it leads to any serious heart problems.
To be eligible for this trial, participants must be at least 18 years old, have confirmed CAD with significant blockage in at least one coronary artery, and have a diagnosis of type 2 diabetes. They should also have a suitable target area for the DCB treatment. However, individuals with certain conditions, such as recent heart attacks, severe liver or kidney issues, or those who are pregnant, will not be able to participate. If you join the study, you will be closely monitored to see how you respond to the treatment, and your experience could help improve care for others with similar health issues in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • Prior coronary artery bypass surgery or PCI with complications
- • STEMI within 24 hours
- • Severe hepatic/renal dysfunction
- • Active bleeding or uncontrolled anticoagulation
- • Allergy to DCB components
- • Pregnancy or lactation
- • Psychiatric conditions limiting compliance
About Shanghai 10th People's Hospital
Shanghai 10th People's Hospital, affiliated with Tongji University, is a leading clinical research institution in China known for its commitment to advancing medical science and improving patient care. With a focus on innovative therapies and cutting-edge research methodologies, the hospital conducts a wide range of clinical trials across various medical disciplines. Its state-of-the-art facilities and multidisciplinary team of experts enable rigorous study designs and high-quality data collection, fostering collaboration with both national and international partners. The hospital is dedicated to upholding ethical standards and promoting patient safety, ensuring that its clinical trials contribute significantly to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Kaifeng, Henan, China
Luoyang, Henan, China
Yibin, Sichuan, China
Zhengzhou, Henan, China
Ningbo, Zhejiang, China
Patients applied
Trial Officials
Yidong Wei, PhD
Principal Investigator
Shanghai 10th People's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported