BIOFLOW III Satellite-Italy Orsiro Stent System

CompletedNCT02028728

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)

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry. The sample size maybe increased in order to reach the subgroup sizes (Diabetes, small vessel, AMI and CTO).

Study details

Official title: Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent Within Daily Clinical Practice III-Italy
Conditions: Coronary Artery Diseases
Sponsor: Biotronik Italia S.p.A.
Start date: 2014-03
Primary completion: 2016-07
Sex: All
Age range: from 18 Years
Results posted: No results posted in this snapshot
Countries: Italy
Total sites listed: 18

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

Inclusion Criteria: * Symptomatic coronary artery disease * Subject signed informed consent for data release * 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 * Pregnancy * Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media * Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained * Currently participating in another study and primary endpoint not reached yet

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02028728