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Coronary Artery DiseaseBIOFLOW-IIINCT01553526

BIOFLOW-III All-comers Orsiro Safety and Performance Registry

An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Biotronik AG at 43 sites in 13 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Myocardial Ischemia
How many people
1,356 participants
Where
43 sitesin 13 countries
Study dates
Aug 2011to Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

43 sites in 13 countries.

43 sites in 13 countries

Germany14 sites

  • Segeberger Kliniken

    Bad Segeberg, 23795

  • Klinikum im Friedrichshain

    Berlin, 10249

  • Kardiologisch-Angiologische Praxis Hegeler

    Bremen, 28277

  • Klinikum Coburg

    Coburg, 96450

  • Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I

    Halle, 06120

  • Asklepiosklinik St. Georg

    Hamburg, 20099

  • Uniklinik Heidelberg, Medizinische Uniklinik

    Heidelberg, 69120

  • Klinikum Landshut-Achdorf Medizinische Klinik I

    Landshut, 84036

  • University of Leipzig

    Leipzig, 04103

  • LMU-Großhadern

    Munich, 81377

  • HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin

    Munich, 81925

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Uniklink Regensburg

    Regensburg, 93053

  • Kliniken Villingen - Kardiologie

    Villingen-Schwenningen, 78050

Other trials in Germany

France9 sites

  • Clinique Rhone Durance

    Avignon, 84082

  • CHU Bocage Dijon

    Dijon, 21034

  • CCML Le Plessis Robinson

    Le Plessis-Robinson, 92350

  • CHRU Brabois Nancy

    Nancy, 54500

  • CH Niort

    Niort, 79000

  • Clinique Saint Hilaire Rouen

    Rouen, 76000

  • CHRU Rangueil Toulouse

    Toulouse, 31403

  • CHG Troyes

    Troyes, 10003

  • CH Valence

    Valence, 26953

Other trials in France

Netherlands6 sites

  • VU Medical Center HV Amsterdam

    Amsterdam, 1081 HV

  • Alysis Hospital

    Arnhem, 6815 AD

  • Amphia Ziekenhuis Breda

    Breda, 4818 CK

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • ZorgSaam Terneuzen

    Terneuzen, 4535 PA

  • Twee Steden Hospital Tilburg

    Tilburg, 5042 AD

Other trials in Netherlands

Italy2 sites

  • Centro cardiologico Monzino

    Milan

  • Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata

    Rome, 00133

Other trials in Italy

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

  • Riga Eastern Clinical University Hospital

    Riga, 1038

Other trials in Latvia

Switzerland2 sites

  • Clinique Cecil

    Lausanne, 1003

  • Kantonsspital Liestal

    Liestal, 4410

Other trials in Switzerland

United Kingdom2 sites

  • Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland

    Belfast, BT63 5QQ

  • The Heart Hospital, UCLH

    London, W1G 8PH

Other trials in United Kingdom

Austria1 site

  • University Hospital Innsbruck

    Innsbruck, 6020

Other trials in Austria

Chile1 site

  • Clinica Tabancura

    Santiago, Vitacura

Other trials in Chile

Denmark1 site

  • Gentofte Universitets Hospital

    Hellerup, 2900

Other trials in Denmark

Portugal1 site

  • Centro Hospitalar de Coimbra

    São Martinho do Bispo, 3041-801

Other trials in Portugal

Spain1 site

  • Hospital de Navarra

    Pamplona, 31008

Other trials in Spain

Sweden1 site

  • Universitetssjukhuset Oerebro, Kardiologiska Kliniken

    Örebro, 701 85

Other trials in Sweden

About this study

Official title: 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).

Read the 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.

Keywords
International, Multicenter, Observational registry, All-comers open label registry, Orsiro Drug Eluting Stent (DES), Stenting, Treatment of Coronary Artery Disease, Coronary revascularization, Percutaneous Coronary Intervention, STEMI, NSTEMI, Ischemia, Angina, Subgroups, Acute Myocardial Infarction, Diabetes, Small Vessels, Chronic Total Occlusion (CTO)
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Ischemia, Angina Pectoris, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01553526
Study groupRoleWhat they receive
Orsiro DESNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Lesion Failure (TLF)

    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)

    Measured: 12 months

Secondary outcomes (6)

  1. Target Lesion Failure (TLF)

    Measured: 6, 36 and 60 months

  2. Target Vessel Revascularization (TVR)

    Any repeat revascularization of the target vessel.

    Measured: 6, 12, 36 and 60 months

  3. Target Lesion Revascularization (TLR)

    Any repeat revascularization of the target lesion.

    Measured: 6, 12, 36 and 60 months

  4. Stent Thrombosis

    Measured: 6, 12, 36 and 60 months

  5. Clinical Device Success

    Measured: At time of intervention

  6. Clinical Procedural Success

    Measured: During the hospital stay to a maximum of the first seven days post index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionMar 2013
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
1,356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01553526
Sponsor's protocol ID
C1101
Acronym
BIOFLOW-III
Status last verified
Aug 2016
First submitted
8 Mar 2012
Last updated
30 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Toelg R, Slagboom T, Waltenberger J, Lefevre T, Saito S, Kandzari DE, Koolen J, Richardt G. Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):848-856. doi: 10.1002/ccd.29254. Epub 2020 Sep 5.

    PubMed 32890442

  • Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Frobert O, Seige M, Friedrich G, Erglis A, Winkens M, Hegeler-Molkewehrum C, Neef M, Hoffmann S; BIOFLOW-III Investigators. Five-Year Results of the Bioflow-III Registry: Real-World Experience with a Biodegradable Polymer Sirolimus-Eluting Stent. Cardiovasc Revasc Med. 2020 Jan;21(1):63-69. doi: 10.1016/j.carrev.2019.03.004. Epub 2019 Mar 15.

    PubMed 30922870

  • Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Frobert O, Seige M, Erglis A, Dewilde W, Winkens M, Hegeler-Molkewehrum C, Klein N, Hoffmann S; BIOFLOW-III Investigators. Real-world experience with a novel biodegradable polymer sirolimus-eluting stent: twelve-month results of the BIOFLOW-III registry. EuroIntervention. 2016 Feb;11(10):1106-10. doi: 10.4244/EIJY15M03_08.

    PubMed 25782184

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Biotronik AG at 43 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Germany, France, Netherlands, Italy, Latvia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01553526, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016; AzTrials last refreshed its copy on 2 Nov 2026.

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