Clinical Trial Details

NCT ID: NCT02257710
Date Last Changed: September 28, 2017


Research Study Summary

A clinical trial to evaluate treatments using Orsiro for patients with Coronary Artery Diseases

Research Study Title

BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III United Kingdom Satellite


Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.

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Recruitment Details

18 and up
Overall Status
Lead Sponsor
Biotronik UK Ltd.
37 Months
Facility Type


All ages 18 Years and up

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 for data release

  • 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

Site Locations (4)

Country State City Zip Facility and Contact
United Kingdom East-Sussex Brighton BN2 5BE Royal Sussex County Hospital
David Hildick-Smith, MD
+441273696955 ext. 4049

David Hildick-Smith, MD
Principal Investigator
United Kingdom Surrey Chertsey KT16 0PZ St Peter's Hospital
Michael Mahmoudi, MD
+44 1932 872000

Michael Mahmoudi, MD
Principal Investigator
United Kingdom Southampton University Hospital Southampton
Michael Mahmoudi
United Kingdom Truro Royal Cornwall Hospital
Trevor Johnston, Dr.


Marcus Knott
+44 (0) 7970084632

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