NCT07009938Not yet recruiting
DCB for CAD With Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 25 May 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shanghai 10th People's Hospital
- Diseases
- Coronary artery disease, Type 2 diabetes
- NCT number
- NCT07009938
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 1 Jul 2025 to the primary completion date, 31 Dec 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior coronary artery bypass surgery or PCI with complications
Other illness
- Active bleeding or uncontrolled anticoagulation
- Allergy to DCB components
- Psychiatric conditions limiting compliance
Other
- STEMI within 24 hours
- Severe hepatic/renal dysfunction
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huaihe Hospital of Henan University Coordinator of this site? Confirm its status | Kaifeng | China | Unknown status |
| Luoyang Central Hospital Affiliated to Zhengzhou University Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Ninghai First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Second People's Hospital of Yibin Coordinator of this site? Confirm its status | Yibin | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou Uninversity Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.