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Clinical Trials/CTRI/2011/10/002088
CTRI/2011/10/002088
Completed
Phase 4

A postmarket surveillance registry of the BioMatrix drug eluting stent in diabetic patients. - EBMX(PMD)

Biosensors Europe SA Morges Switzerland0 sites1,000 target enrollmentTBD
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ConditionsHealth Condition 1: null- Coronary Artery Occlusion

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Coronary Artery Occlusion
Sponsor
Biosensors Europe SA Morges Switzerland
Enrollment
1000
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Pms

Investigators

Sponsor
Biosensors Europe SA Morges Switzerland

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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)

Outcomes

Primary Outcomes

Not specified

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