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BIOFLOW-III Canada Satellite Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik Canada Inc
ClinicalTrials.gov Identifier:
NCT01880242
First received: June 14, 2013
Last updated: September 19, 2017
Last verified: September 2017
June 14, 2013
September 19, 2017
May 13, 2014
August 2017   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01880242 on ClinicalTrials.gov Archive Site
  • Target Lesion Failure [ Time Frame: 6 and 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)
  • 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 ]
    Definite, Probable and Possible Stent Thrombosis
  • Clinical Device Success [ Time Frame: 1 day (At time of intervention) ]
    Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy. Standard predilation catheters and post-dilation catheters (if applicable) may be used.
  • Clinical Procedure Success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ]
    Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents, if applicable) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by visual estimate without using any adjunctive device* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of the first seven days post index procedure.
  • 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 ]
Not Provided
Not Provided
 
BIOFLOW-III Canada Satellite Registry
Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Canada
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.
Not Provided
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)
  • Coronary Artery Disease
  • Myocardial Ischemia
Not Provided
Orsiro DES

Subjects requiring coronary revascularization with Drug Eluting Stents (DES). subgroups: Subjects presenting with

  1. Diabetes (all types)
  2. Small vessels (≤2.75 mm)
  3. Chronic total occlusion (CTO)
  4. Acute Myocardial Infarction (incl. STEMI and NSTEMI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
August 2017
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01880242
G1207
No
Not Provided
Not Provided
Biotronik Canada Inc
Biotronik Canada Inc
Not Provided
Principal Investigator: Samer Mansour, Dr, MD Centre hospitalier de l'Université de Montréal (CHUM)
Biotronik Canada Inc
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP