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BIOFLOW-III Canada Satellite Registry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Biotronik Canada Inc.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Biotronik Canada Inc Identifier:
First received: June 14, 2013
Last updated: January 31, 2015
Last verified: January 2015
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30%-50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures. The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Coronary Artery Disease Myocardial Ischemia

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Biotronik Canada Inc:

Primary Outcome Measures:
  • Target Lesion Failure [ Time Frame: 12 months ]
    Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)

Secondary Outcome Measures:
  • Target Lesion Failure [ Time Frame: 6 and 12 months ]
  • Target Vessel revascularization (TVR) [ Time Frame: 6 and 12 months ]
    Any repeat revascularization of the target vessel

  • Target Lesion Revascularization (TLR) [ Time Frame: 6 and 12 months ]
    Any repeat revascularization of the target lesion

  • Stent Thrombosis [ Time Frame: 6 and 12 months ]
  • Clinical Device Success [ Time Frame: 1 day (At time of intervention) ]
  • Clinical Procedure Success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ]

Estimated Enrollment: 250
Study Start Date: April 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Orsiro DES


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

Inclusion Criteria:

  • Symptomatic coronary artery disease or documented silent ischemia
  • Subject informed consent for data release
  • Subject is geographically stable and willing to participate at all follow ups assessments

Exclusion Criteria:

  • Subject did not sign informed consent for data release
  • Pregnancy
  • Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation/antiplatelet therapy required for PCI, stainless steel, sirolimus
  • Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01880242

Contact: Abby Leung +1-416-620-0069

Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM) Recruiting
Montréal, Quebec, Canada, H2W 1T8
Contact: Samer Mansour, DR, MD    +1- 514-890-8000 ext 15160   
Principal Investigator: Samer Mansour, Dr, MD         
St. Michael's Hospital Recruiting
Toronto, Canada, M5B1WG8
Contact: Michael Kutryk, Dr.    41686460605733   
Sponsors and Collaborators
Biotronik Canada Inc
Principal Investigator: Samer Mansour, Dr, MD Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

Responsible Party: Biotronik Canada Inc Identifier: NCT01880242     History of Changes
Other Study ID Numbers: G1207
Study First Received: June 14, 2013
Last Updated: January 31, 2015

Keywords provided by Biotronik Canada Inc:
Observational registry
Orsiro Drug Eluting Stent (DES)
Treatment of Coronary Artery Disease
Coronary revascularization
Percutaneous Coronary Intervention (PCI)
Acute Myocardial Infarction
Small Vessels
Chronic Total Occlusion (CTO)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes processed this record on September 19, 2017