Patients with Insulin-Treated Diabetes Mellitus and Coronary Artery Disease treated with Drug-Eluting Balloon Post Drug-Eluting Stent Therapy
- Conditions
- Coronary artery disease in insulin-treated diabetic patients
- Registration Number
- NL-OMON24439
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Subject must be above 18 years of age, must have ischemic heart disease that requires PCI, has one or more target lesion(s) suitable for DES implantation, must have insulin-treated diabetes mellitus
Exclusion Criteria
Subject present with STEMI. Target lesion is total occlusion, unprotected left main, located within a graft, instent restenosis, bifurcation with 2-vessel stenting, treatment plan includes stent overlapping
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate lumen loss at 9 months follow-up
- Secondary Outcome Measures
Name Time Method In-stent neointimal hyperplasia volume, target lesion failure, stent thrombosis, angina pectoris