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BIOFLOW-III Belgium Satellite Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01831336
First Posted: April 15, 2013
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biotronik Belgium NV
April 11, 2013
April 15, 2013
September 28, 2017
February 2013
June 2016   (Final data collection date for primary outcome measure)
Target Lesion Failure (TLF) [ 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 NCT01831336 on ClinicalTrials.gov Archive Site
  • 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: 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 Procedural 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 (TLF) [ Time Frame: 6 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 ]
  • Clinical Device Success [ Time Frame: At time of intervention ]
  • Clinical Procedural Success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ]
  • Target Lesion Failure (TLF) [ Time Frame: 6 months ]
Not Provided
Not Provided
 
BIOFLOW-III Belgium Satellite Registry
BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Belgium
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

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 immobilised 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.

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
June 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptomatic coronary artery disease
  • Subject has signed informed consent for data release
  • Subject is geographically stable and willing to participate at all follow-up assessments
  • Subject is ≥ 18 years

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 or contrast media
  • Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
  • Currently participating in another study and primary endpoint is not reached yet.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01831336
G1215
No
Not Provided
Not Provided
Biotronik Belgium NV
Biotronik Belgium NV
Not Provided
Principal Investigator: Victor Legrand, Prof. Dr. CHU Liege (Hospitalo-Facultaire Universitaire de Liège)
Biotronik Belgium NV
September 2017