BIOFLOW III Satellite-ELADIS

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by C.E.M. Biotronik, S.A.
Sponsor:
Information provided by (Responsible Party):
C.E.M. Biotronik, S.A.
ClinicalTrials.gov Identifier:
NCT02029092
First received: December 19, 2013
Last updated: April 14, 2014
Last verified: February 2014

December 19, 2013
April 14, 2014
February 2014
February 2016   (final data collection date for primary outcome measure)
Target Lesion Failure (TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization (TLR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis rate [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Device success [ Time Frame: up to discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
BIOFLOW III Satellite-ELADIS
BIOTRONIK- Safety and Performance Registry for an All Comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice III- ELADIS

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.

Not Provided
Observational [Patient Registry]
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
July 2016
February 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.
Both
18 Years and older
No
Contact: Leticia Mora, Lead Field Clinical Research E +34 636 175 335 leticia.mora@biotronik.com
Contact: Sonia Martin, Clincal Manager +34 649 845298 sonia.martin@biotronik.com
Spain
 
NCT02029092
G1302
No
C.E.M. Biotronik, S.A.
C.E.M. Biotronik, S.A.
Not Provided
Not Provided
C.E.M. Biotronik, S.A.
February 2014

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