ThromboAblation in Acute Myocardial Infarction (TAAMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00650975
Recruitment Status : Terminated (Slow enrollment rate.)
First Posted : April 2, 2008
Last Update Posted : January 20, 2011
Spectranetics Corporation
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Brief Summary:
  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 or disease Intervention/treatment Phase
ST Elevation Acute Myocardial Infarction Device: Laser Thromboablation Device: PTCA (Direct Stenting) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ThromboAblation in Acute Myocardial Infarction
Study Start Date : March 2008
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: ELCA
Laser Thromboablation
Device: Laser Thromboablation
Laser Thromboablation using the Spectranetics CVX-300® excimer laser system

Active Comparator: PTCA
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
Other Names:
  • PCI
  • Direct Stenting

Primary Outcome Measures :
  1. Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE [ Time Frame: 60 minutes - 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00650975

Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology
Katowice, Poland, 40-635
Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital
Krakow, Poland, 31-202
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow, Poland, 31-501
University Hospital No. 1 1st Dept. of Cardiology
Poznan, Poland, 61-848
Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory
Warsaw, Poland, 04-628
Sponsors and Collaborators
Spectranetics Corporation
Principal Investigator: Dariusz Dudek, MD, PhD Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow

Responsible Party: William Kerker, Sr. Manager, Clinical Applications Research, Spectranetics Corporation Identifier: NCT00650975     History of Changes
Other Study ID Numbers: D001747-01
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: January 20, 2011
Last Verified: January 2011

Keywords provided by KCRI:

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