Study Results
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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TERMINATED
NA
1 participants
INTERVENTIONAL
2010-10-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Culprit lesion IRA Revascularization
Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES
IRA stenting in culprit lesion only
stenting
Complete IRA revascularization
Primary PCI of culprit lesion in IRA with DES stent
IRA stenting
Complete IRA revascularization
Interventions
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IRA stenting in culprit lesion only
stenting
IRA stenting
Complete IRA revascularization
Eligibility Criteria
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Inclusion Criteria
* Chest pain onset \<12 hours
* signed informed consent
* Presence of two critical lesions requiring PCI in IRA (LAD - left anterior descending, Cx - circumflex, RCA - right coronary artery)
* Target/culprit lesion which requires immediate stenting (\>50 - 100%) and second critical lesion (70-90%) with TIMI 3 flow after PCI of the 1st target/culprit lesion
* Over 18 years of age
* IRA diameter ≥ 2.5 mm
Exclusion Criteria
* Second critical lesion in IRA \>90% or occlusion
* Contraindications to PCI or/and stent implantation
* Contraindications to DES stent implantation
* Lesion diameters unsuitable for intended stent platform
* Active bleeding or coagulopathy
* Patient in cardiogenic shock (\<90mmHg SBP and/or requiring IABP - intraaortic balloon pump - or vasopressors) - Killip 4 class
* Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
* No future patient cooperation expected
* Patient is participating in another clinical study
18 Years
ALL
No
Sponsors
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Fundacja Ośrodek Badań Medycznych
OTHER
Responsible Party
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Principal Investigators
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Dariusz Dudek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Interventional Cardiology, Jagiellonian University Medical College in Krakow, Poland
Locations
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I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
Warsaw, Banacha 1a, Poland
Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
Krakow, Kraków, Poland
Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
Sanok, Podkarpackie Voivodeship, Poland
SP ZZOZ Powiatowy Szpital Specjalistyczny
Stalowa Wola, Stalowa Wola, Poland
Pracownia Hemodynamiki Szpital im. E. Szczeklika
Tarnów, Szpitalna 13, Poland
Centrum Kardiologii Inwazyjnej GVM Carint
Ostrowiec Świętokrzyski, Szymanowskiego 11, Poland
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
Warsaw, Warszawa, Poland
Centrum Kardiologii Inwazyjnej GVM Carint
Oświęcim, Wysokie Brzegi 4, Poland
Department of Interventional Cardiology, Jagiellonian University Medical College
Krakow, , Poland
Departament of Cardiology, University Hospital, Ljubljana
Ljubljana, Ljubljana, Slovenia
Countries
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Other Identifiers
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3.0/2010
Identifier Type: -
Identifier Source: org_study_id
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