Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients

NCT ID: NCT05937230

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2026-03-01

Brief Summary

Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI). Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel-coated on the balloon.

DCB angioplasty has the following advantages compared to DES implantation: Firstly, the drug in DCB is uniformly distributed and released, whereas the drug release of DES via the stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, and the physiological function of coronary arteries would be maintained.

Currently, DCB constitutes an important treatment option in ISR, which is endorsed by the 2018 European Society of Cardiology Guidelines on myocardial revascularization. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.

Diabetes is associated with worse outcomes after coronary revascularization and has been identified as an independent predictor of adverse events in patients with cardiovascular disease. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB is non-inferior to the drug-eluting stent (DES), there is still a lack of evidence comparing the DCB versus DES for de novo or ISR coronary lesions in diabetic patients. The current study aims to compare the long-term efficacy of DCB to DES in de novo or ISR coronary lesions in diabetic patients.

Conditions

Coronary Heart Disease; Angioplasty, Balloon

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Drug-coated balloon

Paclitaxel coated balloon

Drug-coated balloon

Intervention Type: DEVICE

Paclitaxel is a pharmacologically active substance for anti-neointima.

Drug-eluting stent

Second-generation eluting stents

Drug-eluting stents

Intervention Type: DEVICE

Drug-eluting stent is composed of a metal stent, primer, and drug coating.

Interventions

Drug-coated balloon

Paclitaxel is a pharmacologically active substance for anti-neointima.

Intervention Type: DEVICE

Drug-eluting stents

Drug-eluting stent is composed of a metal stent, primer, and drug coating.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with diabetes mellitus

2. Received PCI by a drug-coated balloons only strategy or drug-eluting stents only strategy

Exclusion Criteria

1. Under the age of 18

2. Unable to give informed consent

3. Currently participating in another trial or participants unable to comply to follow-up

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

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ling Tao, MD, PhD

Professor in Cardiology, Director of the department of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ling Tao, MD, Ph.D.

Role: STUDY_CHAIR

Xijing Hospital

Chao Gao, MD, Ph.D.

Role: STUDY_CHAIR

Xijing Hospital

Locations

Ling Tao

Xi'an, Shannxi, China

Countries

China

Other Identifiers

CAGE-FREE DM registry

Identifier Type: -

Identifier Source: org_study_id