ThromboAblation in Acute Myocardial Infarction

Study Overview
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Brief Summary
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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).

Official Title
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ThromboAblation in Acute Myocardial Infarction

Conditions
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ST Elevation Acute Myocardial Infarction

Intervention / Treatment
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* Device: Laser Thromboablation
* Device: PTCA (Direct Stenting)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ELCA<br>Laser Thromboablation | Device: Laser Thromboablation<br>* Laser Thromboablation using the Spectranetics CVX-300® excimer laser system<br>|
| Active Comparator: PTCA<br>PTCA (Direct Stenting) | Device: PTCA (Direct Stenting)<br>* Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use<br>* Other names: Direct Stenting;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, Laser, Thrombus, Thrombectomy