Everolimus-eluting Bioresorbable Scaffolds for Treatment of Coronary Artery Disease in Patients with Diabetes Mellitus.International, Multicenter, Observational, Prospective Registry Study
Recruiting
- Conditions
- Diabetes Mellitus, Coronary Artery Disease
- Registration Number
- NL-OMON26216
- Lead Sponsor
- Isala Clinics Zwolle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
•Patients aged 18 years or older.
•History of DM
Exclusion Criteria
•Pregnancy
•Patients unable to provide informed consent
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the 1-year composite rate of patient oriented major adverse cardiac events (MACE) defined as a composite of:<br /><br>•Death<br /><br>•Myocardial infarction (MI)<br /><br>•Ischemic-driven target vessel revascularization (TVR) <br>
- Secondary Outcome Measures
Name Time Method To evaluate the 1-year:<br /><br>•Lesion oriented safety and efficacy composite of Cardiac death, MI, target lesion revascularization (TLR)<br /><br>•Patient morbidity oriented endpoint of re-hospitalization due to unstable or crescendo angina pectoris. <br /><br>•Device implantation success<br /><br>•Procedure success<br>