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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KCRI

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Spectranetics Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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