Clinical trial NCT01892917: BIOFLOW-III Hungary Satellite Registry
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Myocardial Ischemia
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)
Lead sponsor: Biotronik Hungária Kft.
Sponsor class: INDUSTRY
First posted: 2013-07-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

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

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 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Target Lesion Failure
timeFrame: 6 and 18 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 6, 12 and 18 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 6, 12 and 18 months
measure: Stent Thrombosis
timeFrame: 6, 12 and 18 months
measure: Clinical Device Success
timeFrame: At time of intervention
measure: Clinical Procedural Success
timeFrame: During the hospital stay to a maximum of the first seven days post index procedure
Other outcomes:
Locations:
city: Balatonfüred
country: Hungary
facility: Állami Szívkórház (State Hospital for cardiology of Balatonfüred)
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiológiai Intézet (Gottsegen György Hungarian Institute of Cardiology)
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház (Bajcsy-Zsilinszky Hospital)
city: Budapest
country: Hungary
facility: SE ÁOK Kardiológiai Központ (Semmelweis University, Heart Center)
city: Debrecen
country: Hungary
facility: DEOEC, Kardiológiai Intézet ( Institute of Cardiology, University of Debrecen)
city: Kaposvár
country: Hungary
facility: Kaposi Mór Oktató Kórház, Kardiológia (Kaposi Mór Teaching Hospital, Cardiology)
city: Nyíregyháza
country: Hungary
facility: Jósa András Kórház, Kardiológia (Jósa András Hospital, Department of Cardiology)
city: Pécs
country: Hungary
facility: PTE ÁOK Szívcentrum (University of Pécs, Faculty of Medicine, Heart Institute)
city: Szeged
country: Hungary
facility: Szentgyörgyi Albert Tudomány Egyetem, ÁOK, Kardiológia (University of Szeged, Albert Szent-Györgyi Clinical Center, Faculty Of Medicine, Second Department of Medicine and Cardiology Centre)
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház, Kardiológia-Hemodinamika (Jász-Nagykun-Szolnok County, Hetényi Géza Hospital, Cardiology, Haemodynamics)
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Kórház Zrt (Vas County, Markusovszky Hospital)
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Kórház (Fejér County Szent György Hospital)
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház, Kardiológia (Zala County Hospital, Cardiology)
Study officials:
affiliation: Semmelweis University
name: Béla Merkely, Prof.
role: PRINCIPAL_INVESTIGATOR
References: