Safety and Performance study in Diabetics with the Limus Eluting Orsiro Stent System in daily clinical practice
- Conditions
- Health Condition 1: null- Diabetic Patients requiring Vascular Intervention with Drug Eluting Stent
- Registration Number
- CTRI/2013/09/003967
- Lead Sponsor
- BIOTRONIK Asia Pacific Pte Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 880
Diabetes Mellitus:
Known Diabetic on Pharmacological treatment.
ACS NSTEMI with documented Hb A1c >7%, even if not on Pharmacological treatment for diabetes.
Subject is >= 18 years of age
Patient has Symptomatic coronary artery disease
Target lesion must be a de novo lesion located in a native coronary artery with reference vessel
diameter >=2.25 mm & <=4.00 mm, lesion length <=40 mm by visual estimate
Patient should be receiving upto 3 stents and upto 2 stents per artery.
Target lesion must be in a major coronary artery
or branch with visually estimated stenosis >=50%
& <100% with TIMI flow>=1.
Subject provides signed informed consent for data release Subject is geographically stable and willing to comply with protocol required follow ups
Pregnant and/or breast-feeding females who
intend to become pregnant during the period of
the registry
Untreatable intolerance to aspirin, clopidogrel,
ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless
steel, Sirolimus or contrast media
Planned surgery within 6 months of PCI unless
dual antiplatelet therapy will be maintained
Currently participating in another study and
primary endpoint is not reached yet.
if the subject has a high probability that a
procedure other than predilatation, stent
implantation and post dilatation will be required at time of index procedure for treatment of target
vessel (e.g. atherectomy, cutting balloon or
brachytherapy).
Patients admitted for treatment of Diabetic
ketoacedosis >= 2 times in the past Six months
(Brittle Diabetics).
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method