BIOFLOW-III Austria Satellite Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Biotronik Vertriebs-GmbH
Sponsor:
Information provided by (Responsible Party):
Biotronik Vertriebs-GmbH
ClinicalTrials.gov Identifier:
NCT01667016
First received: August 15, 2012
Last updated: April 9, 2014
Last verified: April 2013

August 15, 2012
April 9, 2014
August 2012
April 2014   (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), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
Same as current
Complete list of historical versions of study NCT01667016 on ClinicalTrials.gov Archive Site
  • Target Lesion Failure (TLF) [ Time Frame: 6 and 18 months ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: Yes ]
    Any repeat revascularization of the target vessel.
  • Target Lesion Revascularization (TLR) [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: Yes ]
    Any repeat revascularization of the target lesion.
  • Stent Thrombosis [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: Yes ]
  • Clinical Device Success [ Time Frame: At time of intervention ] [ Designated as safety issue: No ]
  • Clinical Procedural 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 Austria 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 Austria

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
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.
 
Recruiting
400
October 2014
April 2014   (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.
Both
18 Years and older
No
Contact: Giovanni Moretti +43 1615 44 50 500 giovanni.moretti@biotronik.com
Austria
 
NCT01667016
G1210
No
Biotronik Vertriebs-GmbH
Biotronik Vertriebs-GmbH
Not Provided
Principal Investigator: Thomas Neunteufl, Prof. Dr. Universitaetsklinik fuer innere Medizin II, Vienna
Biotronik Vertriebs-GmbH
April 2013

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