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
PHASE2/PHASE3
78 participants
INTERVENTIONAL
2008-03-31
2010-01-31
Brief Summary
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2. Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).
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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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ELCA
Laser Thromboablation
Laser Thromboablation
Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
PTCA
PTCA (Direct Stenting)
PTCA (Direct Stenting)
Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use
Interventions
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Laser Thromboablation
Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
PTCA (Direct Stenting)
Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IRA is a native coronary artery; and,
* Reference vessel diameter 2.5 - 4.0 mm; and,
* TIMI 0 or 1 flow with any TIMI thrombus grade; or,
* TIMI 2 or 3 flow with TIMI thrombus grade 3 or greater
Exclusion Criteria
* Previous MI in the distribution of the current IRA
* Previous CABG
* Contraindications to PCI
* allergy(s) to intended study medications
* contraindicated for stent implantation
* Active bleeding or coagulopathy
* Patient in cardiogenic shock (\<90mmHg SBP and/or requiring IABP or vasopressors)
* Known left ventricular ejection fraction (EF) \<30%
* Fibrinolytic administered before PCI
* Renal insufficiency (creatinine \>2.0mg/dl)
* Current vitamin K antagonist therapy or known INR \>1.5
* Known thrombocytopenia - platelets \<100,000 cell count
* Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
* Known history of hemorrhagic stroke (CVA or TIA) \<2 years before screening
* Known or suspected pregnancy
* Current cancer disease
* Comorbidity where survival is anticipated to be \<1 year.
* No future patient cooperation expected
* Patient is participating in another clinical study
* Patient \<18 years of age
18 Years
ALL
No
Sponsors
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Spectranetics Corporation
INDUSTRY
KCRI
OTHER
Responsible Party
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Spectranetics Corporation
Principal Investigators
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Dariusz Dudek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Locations
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Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology
Katowice, , Poland
Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital
Krakow, , Poland
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow, , Poland
University Hospital No. 1 1st Dept. of Cardiology
Poznan, , Poland
Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory
Warsaw, , Poland
Countries
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Other Identifiers
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D001747-01
Identifier Type: -
Identifier Source: org_study_id
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