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
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

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

  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

Locations
Poland
Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology
Katowice, Poland, 40-635
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow, Poland, 31-501
Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital
Krakow, Poland, 31-202
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
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: William Kerker, Sr. Manager, Clinical Applications Research, Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT00650975     History of Changes
Other Study ID Numbers: D001747-01
Study First Received: March 26, 2008
Last Updated: January 19, 2011
Health Authority: Poland: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 17, 2014