BIOFLOW-III Canada Satellite Registry

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Biotronik Canada Inc
Sponsor:
Information provided by (Responsible Party):
Biotronik Canada Inc
ClinicalTrials.gov Identifier:
NCT01880242
First received: June 14, 2013
Last updated: April 8, 2014
Last verified: June 2013

June 14, 2013
April 8, 2014
April 2014
September 2014   (final data collection date for primary outcome measure)
Target Lesion Failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • Target Vessel revascularization (TVR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
    Any repeat revascularization of the target vessel
  • Target Lesion Revascularization (TLR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
    Any repeat revascularization of the target lesion
  • Stent Thrombosis [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Clinical Device Success [ Time Frame: 1 day (At time of intervention) ] [ Designated as safety issue: No ]
  • Clinical Procedure Success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ] [ Designated as safety issue: Yes ]
Same as current
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
250
September 2015
September 2014   (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
Both
18 Years and older
No
Contact: Abby Lung +1-416-620-0069 abby.leung@biotronik.com
Canada
 
NCT01880242
G1207
No
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
June 2013

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