ThromboAblation in Acute Myocardial Infarction
Maneno muhimu
Kikemikali
Tarehe
| Imethibitishwa Mwisho: | 12/31/2010 |
| Iliyowasilishwa Kwanza: | 03/25/2008 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 03/30/2008 |
| Iliyotumwa Kwanza: | 04/01/2008 |
| Sasisho la Mwisho Liliwasilishwa: | 01/18/2011 |
| Sasisho la Mwisho Lilichapishwa: | 01/19/2011 |
| Tarehe halisi ya kuanza kwa masomo: | 02/29/2008 |
| Tarehe ya Kukamilisha Utafiti: | 12/31/2009 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: ELCA
Device: PTCA
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| 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 |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE [60 minutes - 30 days]
