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Thrombus Aspiration for OcLuded Coronary Artery Enhanced With Distal Injection Of Abciximab

NCT01383785 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2012-02-22

No results posted yet for this study

Summary

Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the thrombus occlusion is better than normal injection during primary percutaneous intervention (PCI) for the treatment of acute myocardial infarction. Using this modification of injection method the investigators can achieve less microvascular damage and a reduction of the infarct size with a significant improvement of the outcome at six months.

Conditions

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Hospital Virgen de la Salud

    lead OTHER

Principal Investigators

  • Jose Moreu, Phd,MD · Hospital Virgen de la Salud. Toledo. Spain

  • Luis Rodriguez-Padial, Phd MD · Hospital Virgen de la Salud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01383785 on ClinicalTrials.gov