Patients with Insulin-Treated Diabetes Mellitus and Coronary Artery Disease treated with Drug-Eluting Balloon Post Drug-Eluting Stent Therapy
Phase 3
Recruiting
- Conditions
- athereosclerosis1001108210012653
- Registration Number
- NL-OMON48509
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Insulin-treated diabetes mellitus with coronary artery disease, planned for percutaneous coronary intervention with drug-eluting stent.
Exclusion Criteria
Unable to provide informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In-stent late lumen loss at 9 months follow-up, measured with optical coherence<br /><br>tomography, after PCI with drug-eluting stent followed by drug-coated balloon<br /><br>compared with in-stent late lumen loss after PCI with drug-eluting stent alone<br /><br>in a single lesion. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Device Success at 24 hours; Target Lesion Failure (composite of cardiac death,<br /><br>target vessel myocardial infarction, target lesion revascularization) at 9, 12<br /><br>and 24 months.</p><br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms drive drug-eluting balloon efficacy in insulin-treated diabetes patients with CAD post-stent therapy?
How does drug-eluting balloon compare to standard-of-care treatments for CAD in insulin-dependent diabetes patients after stent placement?
Which biomarkers predict response to drug-eluting balloon therapy in insulin-treated diabetes patients with coronary artery disease (NCT ID: NL-OMON48509)?
What are the known adverse events and management strategies for drug-eluting balloon use in insulin-treated diabetes patients post-stent therapy?
What alternative drug-eluting balloon compounds or combination therapies exist for insulin-dependent diabetes patients with CAD post-stent therapy?