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Sponsors and Collaborators: |
Krakow Cardiovascular Research Institute Spectranetics Corporation |
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Information provided by: | Krakow Cardiovascular Research Institute |
ClinicalTrials.gov Identifier: | NCT00650975 |
Condition | Intervention | Phase |
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ST Elevation Acute Myocardial Infarction |
Device: Laser Thromboablation Device: PTCA (Direct Stenting) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | ThromboAblation in Acute Myocardial Infarction |
Estimated Enrollment: | 200 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ELCA: Active Comparator
Laser Thromboablation
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Device: Laser Thromboablation
Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
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PTCA: Active Comparator
PTCA (Direct Stenting)
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Device: PTCA (Direct Stenting)
Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Electrocardiographic inclusion criteria: (baseline 12-lead ECG recorded at 25 mm/second upon arrival at investigational center)
Angiographic inclusion criteria after crossing with guidewire:
Exclusion Criteria:
Contraindications to PCI
Contact: Dariusz Dudek, MD, PhD | +48124247181 | mcdudek@cyf-kr.edu.pl |
Poland | |
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow | Recruiting |
Krakow, Poland, 31-501 | |
Contact: Dariusz Dudek, MD, PhD +48124247181 mcdudek@cyf-kr.edu.pl | |
Principal Investigator: Dariusz Dudek, MD, PhD | |
Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital | Recruiting |
Krakow, Poland, 31-202 | |
Contact: Krzysztof Zmudka, MD PhD +48126143501 mczmudka@kinga.cyf-kr.edu.pl | |
Principal Investigator: Krzysztof Zmudka, MD, PhD | |
Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology | Recruiting |
Katowice, Poland, 40-635 | |
Contact: Andrzej Ochala, MD, PhD +48323539542 aochala@poczta.onet.pl | |
Principal Investigator: Andrzej Ochala, MD PhD | |
University Hospital No. 1 1st Dept. of Cardiology | Recruiting |
Poznan, Poland, 61-848 | |
Contact: Maciej Lesiak, MD, PhD +48618549223 maciej.lesiak@sk1.am.poznan.pl | |
Principal Investigator: Maciej Lesiak, MD, PhD | |
Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory | Recruiting |
Warsaw, Poland, 04-628 | |
Contact: Adam Witkowski, MD, PhD +48228124164 a.witkowski@ikard.waw.pl | |
Principal Investigator: Adam Witkowski, MD, PhD |
Principal Investigator: | Dariusz Dudek, MD, PhD | Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow |
Responsible Party: | Spectranetics Corporation ( William Kerker, Sr. Manager, Clinical Applications Research ) |
Study ID Numbers: | D001747-01 |
Study First Received: | March 26, 2008 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00650975 History of Changes |
Health Authority: | Poland: Ministry of Health |
STEMI Laser Thrombus Thrombectomy |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction Thrombosis |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |