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BIOFLOW III Satellite-ELADIS Orsiro Stent System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02029092
First Posted: January 7, 2014
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):
C.E.M. Biotronik, S.A.
December 19, 2013
January 7, 2014
September 28, 2017
February 2014
July 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), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
Same as current
Complete list of historical versions of study NCT02029092 on ClinicalTrials.gov Archive Site
  • TLF [ Time Frame: 6 months ]
    Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR).
  • Target Vessel Revascularization (TVR) [ Time Frame: 6 and 12 months ]
    Target Vessel Revascularization (TVR)
  • Target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ]
    Target lesion revascularization (TLR)
  • Stent Thrombosis rate [ Time Frame: 6 and 12 months ]
    Stent Thrombosis rate
  • Device success [ Time Frame: up to discharge ]
    Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device outside the assigned treatment strategy
  • Procedure success [ Time Frame: up to 7 days after procedure ]
    Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device and without the occurrence of ischemia-driven major cardiac event during the hospital stay to a maximum of the first seven days post index procedure.
  • TLF [ Time Frame: 6 months ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 6 and 12 months ]
  • Target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ]
  • Stent Thrombosis rate [ Time Frame: 6 and 12 months ]
  • Device success [ Time Frame: up to discharge ]
    Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device outside the assigned treatment strategy
  • Procedure success [ Time Frame: up to 7 days after procedure ]
    Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation, without using any adjunctive device and without the occurrence of ischemia-driven major cardiac event during the hospital stay to a maximum of the first seven days post index procedure.
Not Provided
Not Provided
 
BIOFLOW III Satellite-ELADIS Orsiro Stent System
BIOTRONIK- Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice III- ELADIS
This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). It 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.

For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil 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 to 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 to 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 neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in 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.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical performance and safety of ORSIRO drug eluting stent system in daily clinical practice.

Observational [Patient Registry]
Observational Model: Other
Time Perspective: Prospective
12 Months
Not Provided
Non-Probability Sample
All subjects requiring coronary revascularization with Drug Eluting Stents (DES)
Coronary Artery Disease
Not Provided
Orsiro
Not Provided
 
Completed
404
July 2016
July 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 of age.

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 after PCI unless dual antiplatelet therapy will be maintained
  • Currently participating in another study and primary endpoint is not yet reached.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT02029092
G1302
No
Not Provided
Not Provided
C.E.M. Biotronik, S.A.
C.E.M. Biotronik, S.A.
Not Provided
Study Director: Sonia Martin CEM BIOTRONIK SA
C.E.M. Biotronik, S.A.
September 2017