A post-marketing surveillance registry of the BioMatrix coronary stent in diabetic patients.
- Conditions
- Health Condition 1: null- Coronary Artery Occlusion
- Registration Number
- CTRI/2011/10/002088
- Lead Sponsor
- Biosensors Europe SA Morges Switzerland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1000
1. Patients must be previously diagnosed with Type I or Type II diabetes with documented treatment with insulin or oral hypoglycemics by medical history. Undocumented or newly diagnosed diabetics must have either blood sugar fasting value of more than 115 mg per dl, post meal 140 mg per dl or glycosylated hemoglobin more than 7.3 percentage (if applicable)
2. Patients that need a treatment with a BioMatrix drug-eluting stent
3. Presence of one or more coronary artery stenoses in a native coronary artery, saphenous bypass graft, or radial vein graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents
3. No limitation on the number of treated lesions, and vessels, and lesion length.
1. Inability to provide informed consent
2. Patients needing additional stent NOT of the Biolimus A9-eluting stent type
3. Patients receiving next to the Biolimus A9-eluting stent also other coronary vascular interventions, for example dilation
4. Patients admitted for treatment of diabetic ketoacidosis 2 times in the past six months (Brittle Diabetics)
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major adverse cardiac events (MACE) within the study population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization.Timepoint: At 12 Months of enrollment.
- Secondary Outcome Measures
Name Time Method Primary and secondary stent thrombosis (definite and probable according to Academic Research Consortium definitions;MACE (Major Adverse Cardiac Events) and TVR (Target Vessel Revascularization)Timepoint: at 1, 6, and 24 months of enrollment.