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Coronary Artery DiseaseNCT01892917

BIOFLOW-III Hungary Satellite Registry

An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Biotronik Hungária Kft. at 13 sites in Hungary.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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
2,000 participants
Where
13 sitesHungary
Study dates
Sep 2012to 31 Dec 2016
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

13 sites in 1 country.

13 sites in 1 country

Hungary13 sites

  • Állami Szívkórház (State Hospital for cardiology of Balatonfüred)

    Balatonfüred, 8231

  • Gottsegen György Országos Kardiológiai Intézet (Gottsegen György Hungarian Institute of Cardiology)

    Budapest, 1096

  • Bajcsy-Zsilinszky Kórház (Bajcsy-Zsilinszky Hospital)

    Budapest, 1106

  • SE ÁOK Kardiológiai Központ (Semmelweis University, Heart Center)

    Budapest, 1122

  • DEOEC, Kardiológiai Intézet ( Institute of Cardiology, University of Debrecen)

    Debrecen, 4012

  • Kaposi Mór Oktató Kórház, Kardiológia (Kaposi Mór Teaching Hospital, Cardiology)

    Kaposvár, 7400

  • Jósa András Kórház, Kardiológia (Jósa András Hospital, Department of Cardiology)

    Nyíregyháza, 4400

  • PTE ÁOK Szívcentrum (University of Pécs, Faculty of Medicine, Heart Institute)

    Pécs, 7624

  • Szentgyörgyi Albert Tudomány Egyetem, ÁOK, Kardiológia (University of Szeged, Albert Szent-Györgyi Clinical Center, Faculty Of Medicine, Second Department of Medicine and Cardiology Centre)

    Szeged, 6720

  • Fejér Megyei Szent György Kórház (Fejér County Szent György Hospital)

    Székesfehérvár, 8001

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház, Kardiológia-Hemodinamika (Jász-Nagykun-Szolnok County, Hetényi Géza Hospital, Cardiology, Haemodynamics)

    Szolnok, 5004

  • Vas Megyei Markusovszky Kórház Zrt (Vas County, Markusovszky Hospital)

    Szombathely, 9400

  • Zala Megyei Kórház, Kardiológia (Zala County Hospital, Cardiology)

    Zalaegerszeg, 8900

Other trials in Hungary

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 Hungary

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, Orsiro Drug Eluting Stent (DES), Stenting, Treatment of Coronary Artery Disease, Coronary revascularization, Percutaneous Coronary Intervention, STEMI, NSTEMI, Ischemia, 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, Diabetes Mellitus

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

    Any target lesion

    Measured: 6 and 18 months

  2. Target Vessel Revascularization (TVR)

    Any repeat revascularization of the target vessel

    Measured: 6, 12 and 18 months

  3. Target Lesion Revascularization (TLR)

    Any repeat revascularization of the target lesion

    Measured: 6, 12 and 18 months

  4. Stent Thrombosis

    Definite, possible and probable

    Measured: 6, 12 and 18 months

  5. Clinical Device Success

    Clinical Device Success

    Measured: At time of intervention

  6. Clinical Procedural Success

    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 posted8 Jul 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2016
  4. Study completion31 Dec 2016

Why it stopped: Sponsors Decision. The collected data are available in a significant proportion and sufficiently enough for an adequate analysis.

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01892917
Sponsor's protocol ID
G1217
Status last verified
Oct 2017
First submitted
2 Jul 2013
Last updated
12 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Biotronik Hungária Kft. at 13 sites in Hungary.

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 4 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: stopped early, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Hungary. 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?

The study was stopped early (reason given: Sponsors Decision. The collected data are available in a significant proportion and sufficiently enough for an adequate analysis.). 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 NCT01892917.

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 12 Oct 2017.

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