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BIOFLOW-III Hungary Satellite Registry

NCT ID: NCT01892917

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Coronary Artery Disease Myocardial Ischemia

Keywords

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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)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik Hungária Kft.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Béla Merkely, Prof.

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

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Állami Szívkórház (State Hospital for cardiology of Balatonfüred)

Balatonfüred, , Hungary

Site Status

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

Budapest, , Hungary

Site Status

Bajcsy-Zsilinszky Kórház (Bajcsy-Zsilinszky Hospital)

Budapest, , Hungary

Site Status

SE ÁOK Kardiológiai Központ (Semmelweis University, Heart Center)

Budapest, , Hungary

Site Status

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

Debrecen, , Hungary

Site Status

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

Kaposvár, , Hungary

Site Status

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

Nyíregyháza, , Hungary

Site Status

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

Pécs, , Hungary

Site Status

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

Site Status

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

Székesfehérvár, , Hungary

Site Status

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

Szolnok, , Hungary

Site Status

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

Szombathely, , Hungary

Site Status

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

Zalaegerszeg, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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G1217

Identifier Type: -

Identifier Source: org_study_id