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ThromboAblation in Acute Myocardial Infarction (TAAMI)

This study has been terminated.
(Slow enrollment rate.)
Spectranetics Corporation
Information provided by:
KCRI Identifier:
First received: March 26, 2008
Last updated: January 19, 2011
Last verified: January 2011
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ThromboAblation in Acute Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by KCRI:

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

Enrollment: 78
Study Start Date: March 2008
Study Completion Date: January 2010
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: William Kerker, Sr. Manager, Clinical Applications Research, Spectranetics Corporation Identifier: NCT00650975     History of Changes
Other Study ID Numbers: D001747-01
Study First Received: March 26, 2008
Last Updated: January 19, 2011

Keywords provided by KCRI:

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on September 19, 2017