Clinical Trials Logo
  1. Home
  2. Coronary Heart Disease
  3. NCT05937230

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

Coronary Heart Disease Clinical Trial

Official title:
Long-Term Performance of Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients: a Real-world, Prospective Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05937230
Study type Observational [Patient Registry]
Source Xijing Hospital
Contact
Status Active, not recruiting
Phase
Start date June 1, 2015
Completion date March 1, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Completed NCT05088291 - Application of a New X-ray Protective Device in Coronary Interventional Therapy
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Not yet recruiting NCT04995159 - Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System N/A
Recruiting NCT02967718 - Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome N/A
Completed NCT02888652 - Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
Terminated NCT02045134 - Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery N/A
Completed NCT02163044 - The Hellenic Postprandial Lipemia Study (HPLS)
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT02753829 - Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease N/A
Completed NCT01826552 - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent Phase 4
Terminated NCT01906957 - Cognition and Exercise Training N/A
Completed NCT02440893 - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Completed NCT01920009 - Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines N/A
Recruiting NCT01689688 - Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography N/A
Completed NCT01779401 - Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients N/A
Recruiting NCT01462799 - COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care N/A
Recruiting NCT01456364 - Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing Phase 4
Completed NCT01486030 - Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test