BIOFLOW III Asia Registry Orsiro Stent System (NCT01941290) | Clinical Trial Compass
CompletedNot Applicable
BIOFLOW III Asia Registry Orsiro Stent System
China, India, Malaysia387 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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.