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BIOFLOW-III Hungary Satellite Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik Hungária Kft.
ClinicalTrials.gov Identifier:
NCT01892917
First received: July 2, 2013
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES)

Condition
Coronary Artery Disease
Myocardial Ischemia

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Further study details as provided by Biotronik Hungária Kft.:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Target Lesion Failure [ 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 ]

Enrollment: 2000
Study Start Date: September 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892917

Locations
Hungary
Állami Szívkórház (State Hospital for cardiology of Balatonfüred)
Balatonfüred, Hungary, 8231
Gottsegen György Országos Kardiológiai Intézet (Gottsegen György Hungarian Institute of Cardiology)
Budapest, Hungary, 1096
Bajcsy-Zsilinszky Kórház (Bajcsy-Zsilinszky Hospital)
Budapest, Hungary, 1106
SE ÁOK Kardiológiai Központ (Semmelweis University, Heart Center)
Budapest, Hungary, 1122
DEOEC, Kardiológiai Intézet ( Institute of Cardiology, University of Debrecen)
Debrecen, Hungary, 4012
Kaposi Mór Oktató Kórház, Kardiológia (Kaposi Mór Teaching Hospital, Cardiology)
Kaposvár, Hungary, 7400
Jósa András Kórház, Kardiológia (Jósa András Hospital, Department of Cardiology)
Nyíregyháza, Hungary, 4400
PTE ÁOK Szívcentrum (University of Pécs, Faculty of Medicine, Heart Institute)
Pécs, Hungary, 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, Hungary, 6720
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház, Kardiológia-Hemodinamika (Jász-Nagykun-Szolnok County, Hetényi Géza Hospital, Cardiology, Haemodynamics)
Szolnok, Hungary, 5004
Vas Megyei Markusovszky Kórház Zrt (Vas County, Markusovszky Hospital)
Szombathely, Hungary, 9400
Fejér Megyei Szent György Kórház (Fejér County Szent György Hospital)
Székesfehérvár, Hungary, 8001
Zala Megyei Kórház, Kardiológia (Zala County Hospital, Cardiology)
Zalaegerszeg, Hungary, 8900
Sponsors and Collaborators
Biotronik Hungária Kft.
Investigators
Principal Investigator: Béla Merkely, Prof. Semmelweis University
  More Information

Responsible Party: Biotronik Hungária Kft.
ClinicalTrials.gov Identifier: NCT01892917     History of Changes
Other Study ID Numbers: G1217 
Study First Received: July 2, 2013
Last Updated: August 29, 2016
Health Authority: Hungary: Scientific and Medical Research Council Ethics Committee

Keywords provided by Biotronik Hungária Kft.:
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)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on December 09, 2016