ThromboAblation in Acute Myocardial Infarction

Phase 2

Terminated

• Conditions: ST Elevation Acute Myocardial Infarction
• Interventions: Device: Laser Thromboablation; Device: PTCA (Direct Stenting)

• Registration Number: NCT00650975
• Lead Sponsor: KCRI

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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-02
• Study Completion: 2010-01
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-19
• Last Update Posted: 2011-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ELCA	Laser Thromboablation	Laser Thromboablation
PTCA	PTCA (Direct Stenting)	PTCA (Direct Stenting)

Primary Outcome Measures

Name	Time	Method
Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE	60 minutes - 30 days

Trial Locations

Locations (5)

Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital; 🇵🇱 Krakow, Poland

Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow; 🇵🇱 Krakow, Poland

Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology; 🇵🇱 Katowice, Poland

University Hospital No. 1 1st Dept. of Cardiology; 🇵🇱 Poznan, Poland

Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory; 🇵🇱 Warsaw, Poland