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BIOFLOW-III Israel Satellite Registry

CompletedNCT01895712
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

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)

BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III

Study details

Official title
Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Canada
Conditions
Sponsor
BIOTRONIK Israel
Start date
2013-08
Primary completion
2015-06
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Israel
Total sites listed
6

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patients with diabetes mellitus Type 1 or 2 * Stable coronary patients with moderate-severe symptomatic angina (CCS ≥II) and evidence of myocardial ischemia per non- invasive test (nuclear or echo) or patients with 'silent' myocardial ischemia and a large (e.g. \>10% of myocardium) territory of myocardium in jeopardy (nuclear or echo) * Subject signed informed consent * Subject is geographically stable and willing to participate at all follow up assessments * Subject is ≥ 18 years of age Exclusion Criteria: * Subject did not sign informed consent * Left main disease * Complex bifurcations * Ostial lesions * Three vessel disease * Large visible thrombus * Heavy calcified lesions needing atherectomy or cutting balloon dilatation * Syntax Score ≥33 * Active bleeding * Sepsis * Chronic total Occlusion * Bleeding tendency obviate dual anti platelet (DAP) intake for one year * Hb\<11/Plts,100.000/WBC\<4000 or \>11.00 * Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following index procedure. (Female subjects of child- bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial) * Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and prasugrel and ticlopidine, inclusive), sirolimus, poly (L-lactide) poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. 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. * Other medical illness (e.g, cancer or congestive heart failure) or Known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01895712