Clinical Trial Details

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

Overview

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

Purpose

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

To Learn more

Recruitment Details

Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Biotronik UK Ltd.
Duration
37 Months
Facility Type
N/A
Compensation

Eligibility

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.

Contact

Marcus Knott
+44 (0) 7970084632
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.