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>