DCB for CAD With Type 2 Diabetes

NCT ID: NCT07009938

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-07-01

Brief 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.

Detailed Description

Coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often coexist, and the long-term hyperglycemic state and metabolic disorders in diabetic patients contribute to endothelial dysfunction and accelerated atherosclerosis. As a result, coronary lesions in T2DM patients tend to be more diffuse and complex, posing greater challenges to percutaneous coronary intervention (PCI). Although drug-eluting stents (DES) have significantly improved clinical outcomes, diabetic patients remain at higher risk for in-stent restenosis (ISR) and target lesion revascularization (TLR), negatively impacting long-term prognosis.

Drug-coated balloons (DCBs), a novel PCI technique, allow for rapid and effective delivery of anti-proliferative agents (e.g. paclitaxel or sirolimus) to the vessel wall without leaving behind a permanent implant. This "leave nothing behind" approach reduces the risk of chronic inflammation and stent-related complications. DCBs have shown promising results in non-diabetic populations, particularly in small vessel disease and bifurcation lesions. However, evidence supporting their use in T2DM patients remains limited, especially from prospective, randomized controlled trials. As such, whether DCBs can serve as a viable alternative to DES in this high-risk group remains an open question.

This study aims to evaluate the efficacy and safety of DCB angioplasty in patients with CAD and T2DM through a prospective, randomized controlled design. The study will focus on restenosis rates, improvement in angina symptoms, incidence of major adverse cardiovascular events (MACE), and patient-reported quality of life outcomes, providing a more individualized and evidence-based treatment approach for this challenging patient population.

Conditions

Coronary Artery Disease; Diabete Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Percutaneous coronary intervention using Drug-Coated Balloon (DCB)

Percutaneous coronary intervention using Drug-Coated Balloon (DCB)

Group Type: EXPERIMENTAL

Drug-Coated Balloon (DCB)

Intervention Type: DEVICE

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.

Either Drug-Eluting Stent (DES) implantation group

Percutaneous coronary intervention using Drug-Eluting Stent (DES) implantation

Group Type: ACTIVE_COMPARATOR

Drug-Eluting Stent (DES) implantation

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yidong Wei, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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

Countries

China

Central Contacts

Yidong Wei, PhD

Role: CONTACT

ywei@tongji.edu.cn

+86-18917683409

Facility Contacts

Ruili He, MD

Role: primary

Gang Li, PhD

Role: primary

+8618810531058

Jiachen Luo, Phd

Role: primary

messichen@tongji.edu.cn

+8618801790469

Xuechuan Dan, MD

Role: primary

Keqiang Lin, MD

Role: primary

Other Identifiers

DCBinT2DM

Identifier Type: -

Identifier Source: org_study_id