DCB for CAD With Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai 10th People's Hospital
About this 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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Prior coronary artery bypass surgery or PCI with complications
STEMI within 24 hours
Severe hepatic/renal dysfunction
Active bleeding or uncontrolled anticoagulation
Trial design
Treatments tested in this trial
- Drug-Coated Balloon (DCB)
- Drug-Eluting Stent (DES) implantation
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov