Status:
TERMINATED
ThromboAblation in Acute Myocardial Infarction
Lead Sponsor:
KCRI
Collaborating Sponsors:
Spectranetics Corporation
Conditions:
ST Elevation Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 elevat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00650975
Start Date
March 1 2008
End Date
January 1 2010
Last Update
January 20 2011
Active Locations (5)
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1
Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology
Katowice, Poland, 40-635
2
Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital
Krakow, Poland, 31-202
3
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow, Poland, 31-501
4
University Hospital No. 1 1st Dept. of Cardiology
Poznan, Poland, 61-848