ThromboAblation in Acute Myocardial Infarction (TAAMI)

January 19, 2011 updated by: KCRI
  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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE
Time Frame: 60 minutes - 30 days
60 minutes - 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KCRI

Collaborators

Spectranetics Corporation

Investigators

  • Principal Investigator: Dariusz Dudek, MD, PhD, Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

January 20, 2011

Last Update Submitted That Met QC Criteria

January 19, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D001747-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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