BIOFLOW-III Hungary Satellite Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Biotronik Hungária Kft.
Sponsor:
Information provided by (Responsible Party):
Biotronik Hungária Kft.
ClinicalTrials.gov Identifier:
NCT01892917
First received: July 2, 2013
Last updated: April 8, 2014
Last verified: July 2013
  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 ]

Estimated Enrollment: 2000
Study Start Date: September 2012
Estimated Primary Completion Date: September 2014 (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
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

Contacts
Contact: Eszter Liptay + 36-1-326-4941 eszter.liptay@biotronik.com

Locations
Hungary
Állami Szívkórház (State Hospital for cardiology of Balatonfüred) Recruiting
Balatonfüred, Hungary, 8231
Contact: Faluközi József, Dr    +36 87 584 580    falukozy@elso.bfkor.hu   
Principal Investigator: Faluközi József         
Bajcsy-Zsilinszky Kórház (Bajcsy-Zsilinszky Hospital) Not yet recruiting
Budapest, Hungary, 1106
Contact: Nagybaczoni Béla, Dr    + 36 1 432-9545    bacom@t-online.hu   
Principal Investigator: Nagybaczoni Béla, Dr         
SE ÁOK Kardiológiai Központ (Semmelweis University, Heart Center) Recruiting
Budapest, Hungary, 1122
Contact: Merkely Béla, Prof Dr    +36 1 458 6840    titkarsag@kardio.sote.hu   
Contact: Szabó György, Dr    +36 1 458 6840    szabogeorgester@gmail.com   
Principal Investigator: Merkely Béla, Prof Dr         
Gottsegen György Országos Kardiológiai Intézet (Gottsegen György Hungarian Institute of Cardiology) Recruiting
Budapest, Hungary, 1096
Contact: Fontos Géza, Dr         
Principal Investigator: Fontos Géza, Dr         
Budai Irgalmasrendi Kórház (Budai Irgalmasrendi Hospital) Not yet recruiting
Budapest, Hungary, 1027
Contact: Zsoldos András, Dr    +36-1-438-8400    andraszsoldos@yahoo.com   
Principal Investigator: Zsoldos András, Dr         
Magyar Honvédség Honvédkórház, Kardiológiai Osztály (Medical Centre, Hungarian Defence Forces, Cardiology Department) Active, not recruiting
Budapest, Hungary, 1134
DEOEC, Kardiológiai Intézet ( Institute of Cardiology, University of Debrecen) Recruiting
Debrecen, Hungary, 4012
Contact: Vajda Gusztáv, Dr    +36 52 255-928    info@debkard.hu   
Principal Investigator: Vajda Gusztáv, Dr         
Petz Aladár Megyei Oktató Kórház, 9024 (Petz Aladár Teaching Hospital) Not yet recruiting
Győr, Hungary, 9024
Contact: Dézsi Csaba, Dr    +36 96 418 244 ext 1817    dcsa@petz.gyor.hu   
Principal Investigator: Dézsi Csaba, Dr         
Kaposi Mór Oktató Kórház, Kardiológia (Kaposi Mór Teaching Hospital, Cardiology) Not yet recruiting
Kaposvár, Hungary, 7400
Contact: Papp Előd, Dr    +36-82-801-813    pappelod@gmail.com   
Principal Investigator: Papp Előd, Dr         
Bács-Kiskun Megyei Önkormányzat Kórháza, Kardiológia (Hospital of Bács-Kiskun County Council, Cardiology) Not yet recruiting
Kecskemét, Hungary, 6000
Contact: Ruzsa Zoltán, Dr    + 36 76 516-700    zruzsa25@gmail.com   
Principal Investigator: Ruzsa Zoltán, Dr         
Borsod-Abaúj-Zemplén Megyei Kórház, Kardiológia (Borsod-Abaúj-Zemplén County Hospital, Cardiology) Not yet recruiting
Miskolc, Hungary, 3526
Contact: Ondrejkó Zsolt, Dr    + 36 46 515-200    korhig@bazmkorhaz.hu   
Principal Investigator: Ondrejkó Zsolt, Dr         
Jósa András Kórház, Kardiológia (Jósa András Hospital, Department of Cardiology) Recruiting
Nyíregyháza, Hungary, 4400
Contact: Kőszegi Zsolt, Dr    +36 42 599-700    koszegi@jaguar.dote.hu   
Principal Investigator: Kőszegi Zsolt, Dr         
PTE ÁOK Szívcentrum (University of Pécs, Faculty of Medicine, Heart Institute) Recruiting
Pécs, Hungary, 7624
Contact: Horváth Iván Docens, Dr    + 36 72 536000    ivan.g.horvath@aok.pte.hu   
Principal Investigator: Horváth Iván Docens, Dr         
Szentgyörgyi Albert Tudomány Egyetem, ÁOK, Kardiológia (University of Szeged, Albert Szent-Györgyi Clinical Center, Faculty Of Medicine, Second Department of Medicine and Cardiology Centre) Recruiting
Szeged, Hungary, 6720
Contact: Ungi Imre, Dr    +36 62 546-492    imre@tipomed.hu   
Principal Investigator: Ungi Imre, Dr         
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház, Kardiológia-Hemodinamika (Jász-Nagykun-Szolnok County, Hetényi Géza Hospital, Cardiology, Haemodynamics) Recruiting
Szolnok, Hungary, 5004
Contact: Szabó György, Dr.    + 36 56 503 603    szabogeorgester@gmail.com   
Principal Investigator: Szabó György, Dr         
Vas Megyei Markusovszky Kórház Zrt (Vas County, Markusovszky Hospital) Recruiting
Szombathely, Hungary, 9400
Contact: Nagy Lajos, Prof Dr    + 36 94 311 542    nagy.lajos@markusovszky.hu   
Principal Investigator: Nagy Lajos, Dr         
Fejér Megyei Szent György Kórház (Fejér County Szent György Hospital) Recruiting
Székesfehérvár, Hungary, 8001
Contact: Bokori György, Dr    + 36 20-944-9161    gy.bokori@freemail.hu   
Principal Investigator: Bokori György, Dr         
Zala Megyei Kórház, Kardiológia (Zala County Hospital, Cardiology) Recruiting
Zalaegerszeg, Hungary, 8900
Contact: Lupkovics Géza, Dr    +36 92 507 500 ext 1240    zalahemo@zalaszam.hu   
Principal Investigator: Lupkovics Géza, Dr         
Sponsors and Collaborators
Biotronik Hungária Kft.
Investigators
Principal Investigator: Béla Merkely, Prof. Semmelweis University
  More Information

No publications provided

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: April 8, 2014
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 October 01, 2014