Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction (PEBSI-01)

February 5, 2015 updated by: Francisco Javier Goicolea

Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction After Bare Metal Stent Insertion

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 patients with acute myocardial infarction with systolic time elevation of less than 12 hours of evolution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 a 1:1 ratio to one of the following treatment groups:

Group 1: post-dilatation with a paclitaxel eluting balloon (Pantera Lux ®) Group 2: no post-dilatation Patients (or their legal representative) must sign the consent before randomization.

After surgery, patients will be treated with dual antiplatelet therapy (aspirin plus clopidogrel) for at least one month to group 2 patients; and at least 3 months in those who are also treated with the paclitaxel eluting balloon (group 1). Aspirin is prescribed indefinitely according to the usual practice in these patients.

Patients will be monitored 30 days after surgery, at 6 and 12 months, and the ninth month (in which patient will receive an angiographic control).

The primary efficacy endpoint is late lumen loss (PLT) comparing it value during surgery and control angiography at 9 months

This study will involve patients over 18 years olds with systolic time elevation myocardial infarction, or new left bundle branch block or posterior AMI (ECG) that occur within 12 hours of onset of symptoms to treatment by primary angioplasty.

They include a total of 220 patients.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Hospital General Universitario de Albacete
      • Badajoz, Spain, 06006
        • H. Regional Universitario Infanta Cristina
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08035
        • Hospital Universitario Valle de Hebrón
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcántara
      • Granada, Spain, 18012
        • Hospital Universitario Virgen de Las Nieves
      • Lleida, Spain, 25198
        • Hospital Arnau de Vilanova
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Málaga, Spain, 29010
        • Hospital Regional Universitario Carlos Haya
      • Málaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
      • Sevilla, Spain, 41071
        • Hospital Universitario Virgen Macarena
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Complexo Hospitalario de Santiago
    • Cádiz
      • Puerto Real, Cádiz, Spain, 11510
        • Hospital Universitario Puerto Real
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07120
        • Hospital Son Espases
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Virgen de la Arrixaca
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital de Navarra
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital Galdakao-Usanso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bare metal Stent plus Paclitaxel Balloon
Conventional bare metal Stent plus Paclitaxel Eluting Balloon(Pantera Lux)®
Device: Bare metal Stent plus Paclitaxel Balloon
After the permeabilization of the clinical event responsible artery with conventional therapy (including the insertion of a conventional metal stent and once by the interventional cardiologist gives good final result), patients will be randomized in a 1:1 ratio
Other Names:
  • Balloon PANTERA LUX (R)
Active Comparator: Bare metal Stent
Conventional Bare Stent
Device: Bare metal Stent
After the permeabilization of the clinical event responsible artery with conventional therapy a conventional metal stent will be inserted. Once by the interventional cardiologist gives good final result), patients will be randomized in a 1:1 ratio
Other Names:
  • PROKINETIC ENERGY (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late Luminal Loss
Time Frame: 1 year
Loss measured in millimeters of late luminal space in vessels
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 1 year
Efficacy: angiography restenosis, minimal luminal diameter, ischemia directed target vessel revascularization (TVR), MACE (death, infarction, TVR)
1 year
Safety
Time Frame: 1 year
Safety: MACE/ month, at 6 months and 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francisco Javier Goicolea

Collaborators

Effice Servicios Para la Investigacion S.L.

Investigators

  • Study Director: Francisco J. Goicolea, PhD, Hospital Universitario Puerta de Hierro. Majadahonda. Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

February 6, 2015

Last Update Submitted That Met QC Criteria

February 5, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEBSI-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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