ST Elevation Acute Myocardial Infarction
Conditions
Keywords
STEMI, Laser, Thrombus, Thrombectomy
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).
Interventions
DEVICELaser Thromboablation
Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
DEVICEPTCA (Direct Stenting)
Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use
Sponsors
Spectranetics Corporation
KCRI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE | 60 minutes - 30 days |
Countries
Poland
Outcome results
None listed