BIOFLOW III Asia Registry Orsiro Stent System (NCT01941290) | Clinical Trial Compass
CompletedNot Applicable
BIOFLOW III Asia Registry Orsiro Stent System
China, India387 participantsStarted 2013-10
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ves…