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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Drug-Coated Balloon (DCB)
DeviceFollowing 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
DeviceAfter 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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Percutaneous coronary intervention using Drug-Coated Balloon (DCB)Experimental treatment 1 intervention
Group B: Either Drug-Eluting Stent (DES) implantation groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Target Lesion Diameter Stenosis Rate
Target Lesion Diameter Stenosis Rate refers to the percentage of narrowing at the target coronary lesion, calculated by comparing the minimal lumen diameter (MLD) at the lesion site with the reference vessel diameter (RVD), which was measured based on coronary angiography.
Time frame
At 12 months after interventionSecondary outcomes
1
Major Adverse Cardiovascular Events (MACE)
A composite of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis)
Time frame
At 12 months after intervention2
Angina Symptom Improvement
Measured by Seattle Angina Questionnaire (SAQ) at baseline, 1, 3, and 6 months.
Time frame
At baseline, 1, 3, 6 and 12 months after intervention3
Changes in glycemic indices including glycated hemoglobin (HbA1c)
Changes in glycemic indices including glycated hemoglobin (HbA1c)
Time frame
At 3, 6 and 12 months after intervention4
Glycemic indices
Changes in fasting blood glucose, and 2-hour postprandial blood glucose levels
Time frame
At 3, 6 and 12 months after interventionSponsors and contacts
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Source ClinicalTrials.gov
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