DCB for CAD With Type 2 Diabetes

NCT07009938 | Not Yet Recruiting DMC

• 1 other identifier: DCBinT2DM
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Artery Disease; Diabete Type 2

Keywords

coronary artery disease; type 2 diabetes mellitus; drug-coated balloon; target lesion revascularization; major adverse cardiac events

Outcome Measures

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.

  At 12 months after intervention

Secondary Outcomes (4)

• Major Adverse Cardiovascular Events (MACE)

  At 12 months after intervention

• Angina Symptom Improvement

  At baseline, 1, 3, 6 and 12 months after intervention

• Changes in glycemic indices including glycated hemoglobin (HbA1c)

  At 3, 6 and 12 months after intervention

• Glycemic indices

  At 3, 6 and 12 months after intervention

Study Arms (2)

Percutaneous coronary intervention using Drug-Coated Balloon (DCB)

EXPERIMENTAL

Percutaneous coronary intervention using Drug-Coated Balloon (DCB)

Device: Drug-Coated Balloon (DCB)

Either Drug-Eluting Stent (DES) implantation group

ACTIVE COMPARATOR

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

Device: Drug-Eluting Stent (DES) implantation

Interventions

Drug-Coated Balloon (DCB) 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.

Percutaneous coronary intervention using Drug-Coated Balloon (DCB)

Drug-Eluting Stent (DES) implantation 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.

Either Drug-Eluting Stent (DES) implantation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (6)

Huaihe Hospital of Henan University

Kaifeng, Henan, China

Location

Luoyang Central Hospital Affiliated to Zhengzhou University

Luoyang, Henan, China

Location

The First Affiliated Hospital of Zhengzhou Uninversity

Zhengzhou, Henan, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

The Second People's Hospital of Yibin

Yibin, Sichuan, China

Location

Ninghai First Hospital

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Yidong Wei, PhD

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yidong Wei, PhD

CONTACT

+86-18917683409; ywei@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-05

Locations

CN (6)