ThromboAblation in Acute Myocardial Infarction (TAAMI)

This study has been terminated.
(Slow enrollment rate.)
Sponsor:
Collaborator:
Spectranetics Corporation
Information provided by:
Krakow Cardiovascular Research Institute
ClinicalTrials.gov Identifier:
NCT00650975
First received: March 26, 2008
Last updated: January 19, 2011
Last verified: January 2011

March 26, 2008
January 19, 2011
March 2008
Not Provided
Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE [ Time Frame: 60 minutes - 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00650975 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
ThromboAblation in Acute Myocardial Infarction
ThromboAblation in Acute Myocardial Infarction
  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).
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
ST Elevation Acute Myocardial Infarction
  • Device: Laser Thromboablation
    Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
  • 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
  • Active Comparator: ELCA
    Laser Thromboablation
    Intervention: Device: Laser Thromboablation
  • Active Comparator: PTCA
    PTCA (Direct Stenting)
    Intervention: Device: PTCA (Direct Stenting)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
78
January 2010
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00650975
D001747-01
Yes
William Kerker, Sr. Manager, Clinical Applications Research, Spectranetics Corporation
Krakow Cardiovascular Research Institute
Spectranetics Corporation
Principal Investigator: Dariusz Dudek, MD, PhD Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow Cardiovascular Research Institute
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP