BIOFLOW-III All-comers Orsiro Safety and Performance Registry (BIOFLOW-III)

August 29, 2016 updated by: Biotronik AG

BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1356

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • University Hospital Innsbruck
  • Chile
      • Santiago, Chile, Vitacura
        • Clinica Tabancura
  • Denmark
      • Hellerup, Denmark, 2900
        • Gentofte Universitets Hospital
  • France
      • Avignon, France, 84082
        • Clinique Rhône Durance
      • Dijon, France, 21034
        • CHU Bocage Dijon
      • Le Plessis Robinson, France, 92350
        • CCML Le Plessis Robinson
      • Nancy, France, 54500
        • CHRU Brabois Nancy
      • Niort, France, 79000
        • CH Niort
      • Rouen, France, 76000
        • Clinique Saint Hilaire Rouen
      • Toulouse, France, 31403
        • CHRU Rangueil Toulouse
      • Troyes, France, 10003
        • CHG Troyes
      • Valence, France, 26953
        • CH Valence
  • Germany
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken
      • Berlin, Germany, 10249
        • Klinikum im Friedrichshain
      • Bremen, Germany, 28277
        • Kardiologisch-Angiologische Praxis Hegeler
      • Coburg, Germany, 96450
        • Klinikum Coburg
      • Halle, Germany, 06120
        • Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I
      • Hamburg, Germany, 20099
        • Asklepiosklinik St. Georg
      • Heidelberg, Germany, 69120
        • Uniklinik Heidelberg, Medizinische Uniklinik
      • Landshut, Germany, 84036
        • Klinikum Landshut-Achdorf Medizinische Klinik I
      • Leipzig, Germany, 04103
        • University of Leipzig
      • Muenster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Munich, Germany, 81377
        • LMU-Großhadern
      • Munich, Germany, 81925
        • HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin
      • Regensburg, Germany, 93053
        • Uniklink Regensburg
      • Villingen-Schwenningen, Germany, 78050
        • Kliniken Villingen - Kardiologie
  • Italy
      • Milano, Italy
        • Centro Cardiologico Monzino
      • Rome, Italy, 00133
        • Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia, 1038
        • Riga Eastern Clinical University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU Medical Center HV Amsterdam
      • Arnhem, Netherlands, 6815 AD
        • Alysis Hospital
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis Breda
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis
      • Terneuzen, Netherlands, 4535 PA
        • ZorgSaam Terneuzen
      • Tilburg, Netherlands, 5042 AD
        • Twee Steden Hospital Tilburg
  • Portugal
      • Sao Martinho do Bispo, Portugal, 3041-801
        • Centro Hospitalar de Coimbra
  • Spain
      • Pamplona, Spain, 31008
        • Hospital de Navarra
  • Sweden
      • Oerebro, Sweden, 701 85
        • Universitetssjukhuset Oerebro, Kardiologiska Kliniken
  • Switzerland
      • Lausanne, Switzerland, 1003
        • Clinique Cecil
      • Liestal, Switzerland, 4410
        • Kantonsspital Liestal
  • United Kingdom
      • Belfast, United Kingdom, BT63 5QQ
        • Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland
      • London, United Kingdom, W1G 8PH
        • The Heart Hospital, UCLH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Orsiro DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 6, 36 and 60 months
6, 36 and 60 months
Target Vessel Revascularization (TVR)
Time Frame: 6, 12, 36 and 60 months
Any repeat revascularization of the target vessel.
6, 12, 36 and 60 months
Target Lesion Revascularization (TLR)
Time Frame: 6, 12, 36 and 60 months
Any repeat revascularization of the target lesion.
6, 12, 36 and 60 months
Stent Thrombosis
Time Frame: 6, 12, 36 and 60 months
6, 12, 36 and 60 months
Clinical Device Success
Time Frame: At time of intervention
At time of intervention
Clinical Procedural Success
Time Frame: During the hospital stay to a maximum of the first seven days post index procedure
During the hospital stay to a maximum of the first seven days post index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik AG

Investigators

  • Study Director: Esther Gerteis, Biotronik AG
  • Principal Investigator: Johannes Waltenberger, Prof., University Hospital Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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