ThromboAblation in Acute Myocardial Infarction
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 12/31/2010 |
| Pirmasis pateikimas: | 03/25/2008 |
| Numatytas registravimas pateiktas: | 03/30/2008 |
| Pirmas paskelbtas: | 04/01/2008 |
| Paskutinis atnaujinimas pateiktas: | 01/18/2011 |
| Paskutinis atnaujinimas paskelbtas: | 01/19/2011 |
| Faktinė studijų pradžios data: | 02/29/2008 |
| Numatoma studijų užbaigimo data: | 12/31/2009 |
Būklė ar liga
Intervencija / gydymas
Device: ELCA
Device: PTCA
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Active Comparator: ELCA Laser Thromboablation | Device: ELCA Laser Thromboablation using the Spectranetics CVX-300® excimer laser system |
| Active Comparator: PTCA PTCA (Direct Stenting) | Device: PTCA Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE [60 minutes - 30 days]
