BIOFLOW III Asia Registry Orsiro Stent System
CompletedNCT01941290
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Cliflical evaluation of th' Orsiro LESS 10 diabetic subjects requiring coronary revasculariza t ion with Drug Eluting Stefl ts (DES) .880 subjects will be enrolled in this registry. The sample subjects size may be increased in order to reach the subgroup sizes (Small Vessel and AMI).
Study details
- Official title
- Biotronik-Safety and Performance Registry for an All-comers Diabetic Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice-III Asia
- Conditions
- Coronary Artery Disease
- Myocardial Ischemia
- Diabetes Mellitus Type 1 or 2
- Sponsor
- BIOTRONIK Asia Pacific Pte Ltd
- Start date
- 2013-10
- Primary completion
- 2017-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- China, India, Malaysia, Sri Lanka, Vietnam
- Total sites listed
- 19
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Inclusion Criteria * Diabetes Mellitus: * Known Diabetic on Pharmacological treatment. * ACS NSTEMI with documented Hb A1c\> 7%, even if not on Pharmacological treatment for diabetes. * 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 up to 3 stents and up to 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 * Subject is ≥ 18 years of age Exclusion Criteria: * 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 ketoacidosis ≥ 2 times in the past Six months (Brittle Diabetics).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01941290