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ThromboAblation in Acute Myocardial Infarction (TAAMI)
This study is currently recruiting participants.
Verified by Krakow Cardiovascular Research Institute, May 2008
First Received: March 26, 2008   Last Updated: May 30, 2008   History of Changes
Sponsors and Collaborators: Krakow Cardiovascular Research Institute
Spectranetics Corporation
Information provided by: Krakow Cardiovascular Research Institute
ClinicalTrials.gov Identifier: NCT00650975
  Purpose
  1. Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related artery (IRA) stenting results in improved reperfusion success in patients presenting with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident thrombus.
  2. Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).

Condition Intervention Phase
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

Resource links provided by NLM:


Further study details as provided by Krakow Cardiovascular Research Institute:

Primary Outcome Measures:
  • Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE [ Time Frame: 60 minutes - 30 days ] [ Designated as safety issue: Yes ]

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
ELCA: Active Comparator
Laser Thromboablation
Device: Laser Thromboablation
Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
PTCA: Active Comparator
PTCA (Direct Stenting)
Device: PTCA (Direct Stenting)
Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Electrocardiographic inclusion criteria: (baseline 12-lead ECG recorded at 25 mm/second upon arrival at investigational center)

  • STEMI within 12 hours of symptom onset, with ≥ 2 mm ST segment elevation in two or more leads and minimum ≥ 3 mm ST segment elevation in one lead.

Angiographic inclusion criteria after crossing with guidewire:

  • 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:

  • Patient unwilling or unable to give informed consent
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650975

Contacts
Contact: Dariusz Dudek, MD, PhD +48124247181 mcdudek@cyf-kr.edu.pl

Locations
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            
Sponsors and Collaborators
Krakow Cardiovascular Research Institute
Spectranetics Corporation
Investigators
Principal Investigator: Dariusz Dudek, MD, PhD Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
  More Information

No publications provided

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

Keywords provided by Krakow Cardiovascular Research Institute:
STEMI
Laser
Thrombus
Thrombectomy

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction
Thrombosis

Additional relevant MeSH terms:
Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 11, 2009