Status:
COMPLETED
Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction
Lead Sponsor:
Francisco Javier Goicolea
Collaborating Sponsors:
Effice Servicios Para la Investigacion S.L.
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study objective is the evaluation of safety and efficacy at 9 months of combination treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs bare metal stent (conventional treatment) in patien...
Detailed Description
This is a multicenter, prospective, randomized, open study After the permeabilization of the clinical event responsible artery and the insertion of a bare metal stent, patients will be randomized in ...
Eligibility Criteria
Inclusion
- Patients aged less than 18 years.
- Acute myocardial infarction (AMI) within 12 hours of evolution (from the onset of symptoms) systolic time elevation of at least 1 mm (recorded in two or more contiguous leads), new left bundle branch block, or true posterior infarction.
- Patients candidates for primary angioplasty as medical criteria
- Written informed consent according to International Conference on Harmonization / Guide Clinical Practice and local legislation, obtained before any study procedure.
- Diameter vascular coronary artery to treat between 2 mm and 4 mm.
- Patients with 90-100% stenosis.
Exclusion
- Patients who refuse to participate in the study
- Cardiogenic shock (defined as systolic blood pressure less than 80 mm Hg for more than 30 minutes or need for vasopressors or intra-aortic balloon counterpulsation)
- Concomitant diseases associated with a life expectancy of less than one year
- Angiographic variables:
- Trunk unprotected
- Branching (side branch greater than 2.5 mm)
- Sinus tachycardia segment elevation myocardial infarction thrombosis secondary to stent
- If more than one stent to treat a single segment (overlapping stents).
- Patient candidate for surgical revascularization within 30 days
- Stenosis of greater than 30 mm in length (corresponding with the ball longer available)
- Reference vessel diameter less than 2.5 mm and greater than 4 mm (larger ball)
- More severe stenosis in the same artery in which is expected to be addressed in the next 9 months
- Women at childbearing age, where there is the possibility of pregnancy during the first year of follow-up, or nursing.
- Any clinical condition, which in the opinion of the investigator, is considered clinically significant as to participate in the study.
- Subjects who are participating in any study drug or medical.
- Individuals who show inability to follow instructions or help during the course of the study.
- Bleeding diathesis or other disorders such as gastrointestinal ulceration or cerebral circulatory disorders, restricting the use of treatments platelet aggregation inhibitors and anticoagulants.
- Patients with an ejection fraction \<30% (if known).
- Allergy or hypersensitivity to paclitaxel intolerance, or compounds structurally related to the Butyryl tri-n-hexyl citrate (BTHC) matrix of administration.
- Severe allergy to contrast media.
- Coronary artery spasm in the absence of significant stenosis.
- Cases in which is indicated bypass surgery within 30 days after infarction.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT01839890
Start Date
April 1 2012
End Date
June 1 2014
Last Update
February 6 2015
Active Locations (19)
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1
Complexo Hospitalario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
2
Hospital General Universitario de Albacete
Albacete, Albacete, Spain, 02006
3
H. Regional Universitario Infanta Cristina
Badajoz, Badajoz, Spain, 06006
4
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120