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ThromboAblation in Acute Myocardial Infarction (TAAMI)

Primary Purpose

ST Elevation Acute Myocardial Infarction

Status
Terminated
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Laser Thromboablation
PTCA (Direct Stenting)
Sponsored by
KCRI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Acute Myocardial Infarction focused on measuring STEMI, Laser, Thrombus, Thrombectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology
  • Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital
  • Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
  • University Hospital No. 1 1st Dept. of Cardiology
  • Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ELCA

PTCA

Arm Description

Laser Thromboablation

PTCA (Direct Stenting)

Outcomes

Primary Outcome Measures

Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE

Secondary Outcome Measures

Full Information

First Posted
March 26, 2008
Last Updated
January 19, 2011
Sponsor
KCRI
Collaborators
Spectranetics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00650975
Brief Title
ThromboAblation in Acute Myocardial Infarction
Acronym
TAAMI
Official Title
ThromboAblation in Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment rate.
Study Start Date
March 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
KCRI
Collaborators
Spectranetics Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Acute Myocardial Infarction
Keywords
STEMI, Laser, Thrombus, Thrombectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ELCA
Arm Type
Active Comparator
Arm Description
Laser Thromboablation
Arm Title
PTCA
Arm Type
Active Comparator
Arm Description
PTCA (Direct Stenting)
Intervention Type
Device
Intervention Name(s)
Laser Thromboablation
Intervention Description
Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
Intervention Type
Device
Intervention Name(s)
PTCA (Direct Stenting)
Other Intervention Name(s)
PCI, Direct Stenting
Intervention Description
Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use
Primary Outcome Measure Information:
Title
Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE
Time Frame
60 minutes - 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariusz Dudek, MD, PhD
Organizational Affiliation
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
University Hospital No. 1 1st Dept. of Cardiology
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland

12. IPD Sharing Statement

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ThromboAblation in Acute Myocardial Infarction

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