Thrombus Aspiration for OcLuded Coronary Artery Enhanced With Distal Injection Of Abciximab
NCT ID: NCT01383785
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
186 participants
INTERVENTIONAL
2009-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GROUP A
Intracoronary full bolus dose of abciximab proximal to thrombus occlusion
Intracoronary direct injection
Abciximab bolus dosage: 0,125 mg/kg.
Group A: Intracoronary full bolus dose of abciximab proximal to thrombus occlusion. The investigators inject the bolus of abciximab by catheter guide before cross the occlusion. This in the normal way in study' laboratory.
GROUP B
Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter
Intracoronary and distal injection by aspiration device
Abciximab bolus dosage: 0,125 mg/kg.
Group B: Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter. The investigators inject half of the dose like group A and the other half like group C.
GROUP C
Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter
Intracoronary distal injection by aspiration catheter device
Abciximab bolus dosage: 0,125 mg/kg.
Group C: Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter. The investigators inject the bolus after cross the occlusion using an aspiration catheter.
Interventions
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Intracoronary direct injection
Abciximab bolus dosage: 0,125 mg/kg.
Group A: Intracoronary full bolus dose of abciximab proximal to thrombus occlusion. The investigators inject the bolus of abciximab by catheter guide before cross the occlusion. This in the normal way in study' laboratory.
Intracoronary and distal injection by aspiration device
Abciximab bolus dosage: 0,125 mg/kg.
Group B: Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter. The investigators inject half of the dose like group A and the other half like group C.
Intracoronary distal injection by aspiration catheter device
Abciximab bolus dosage: 0,125 mg/kg.
Group C: Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter. The investigators inject the bolus after cross the occlusion using an aspiration catheter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* TIMI flow 2 or 3
* Life expectance less than 6 months
* Contraindication to AAS, clopidogrel or abciximab
* Severe tortuosity of occluded vessel
18 Years
75 Years
ALL
No
Sponsors
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Hospital Virgen de la Salud
OTHER
Responsible Party
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J.Moreu
Director catheterization laboratory
Principal Investigators
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Jose Moreu, Phd,MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Virgen de la Salud. Toledo. Spain
Luis Rodriguez-Padial, Phd MD
Role: STUDY_DIRECTOR
Hospital Virgen de la Salud
Locations
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Hospital Virgen de la Salud
Toledo, Toledo, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.
Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416.
Vetrovec GW. Improving reperfusion in patients with myocardial infarction. N Engl J Med. 2008 Feb 7;358(6):634-7. doi: 10.1056/NEJMe0708910. No abstract available.
Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.
Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006.
Other Identifiers
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PI-2008/52
Identifier Type: -
Identifier Source: org_study_id
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