Paclitaxel Eluting Balloon After Bare Metal Stent Implantation vs. Drug-Eluting Stent in St Elevation Myocardial Infarction (PEBSI-2)

May 21, 2020 updated by: Arturo García-Touchard, Fundacion Investigacion Interhospitalaria Cardiovascular

Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon After Bare Metal Stent Implantation Versus Drug-eluting Stent in St Elevation Myocardial Infarction

Study objective is the evaluation of safety and efficacy at 12 months of the combination treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs drug eluting stent in patients with ST-elevation myocardial infarction with less than 12 hours of evolution.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, prospective, randomized, open study

After the permeabilization of the clinical event responsible artery patients will be randomized in a 1:1 ratio to one of the following treatment groups:

Group 1: insertion of a bare metal stent with post-dilatation with a paclitaxel eluting balloon (Pantera Lux ®)

Group 2: insertion of a drug elution stent

Patients (or their legal representative) must sign the consent before randomization.

Patients will be monitored 30 days after surgery, at 6 and 12 months.

The primary efficacy endpoint is Target Vessel Failure (TVF) at 12 months

This study will involve patients over 18 years old with STEMI, or new left bundle branch block or posterior AMI (ECG) that occur within 12 hours of onset of symptoms.

A total of 516 patients will be included.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

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, 05200
        • Complejo Hospitalario U. de Albacete
      • Barcelona, Spain, 08036
        • H. Clinic
      • Barcelona, Spain, 08003
        • H. del Mar
      • Barcelona, Spain, 08035
        • H. U. Vall D'Hebron
      • Ciudad Real, Spain, 13005
        • H. General U. de Ciudad Real
      • Granada, Spain, 18014
        • H. U. Virgen de las Nieves
      • Madrid, Spain, 28040
        • H. Clínico San Carlos
      • Madrid, Spain, 28041
        • H. U. 12 de Octubre
      • Madrid, Spain, 28006
        • H. U. de la Princesa
      • Madrid, Spain, 28222
        • H. U. Puerta de Hierro Majadahonda
      • Málaga, Spain, 29011
        • H. Regional U. de Málaga
      • Valencia, Spain, 46026
        • H. U. i Politècnic La Fe de Valencia
      • Valladolid, Spain, 47003
        • H. Clínico U. de Valladolid
    • Baleares
      • Palma De Mallorca, Baleares, Spain, 07120
        • H. U. Son Espases
    • Cádiz
      • Puerto Real, Cádiz, Spain, 11510
        • H. U. Puerto Real
    • H. U. De Bellvitge
      • L'Hospitalet De Llobregat, H. U. De Bellvitge, Spain, 08907
        • H. U. de Bellvitge

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 to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged equal or older 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 85-100% stenosis and TIMI Score (Thrombolysis In Myocardial Infarction) of 0-I.

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)
    • 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.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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
ACTIVE_COMPARATOR: Drug-Eluting Stent (DES)
Sirolimus Eluting Stent (Orsiro®)
Device: Drug Eluting Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Vessel Failure (TVF)
Time Frame: 1 year
Efficacy: TVF define as a the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Revascularization (TLR)
Time Frame: 1 year
Efficacy: ischemia-driven target-lesion revascularization
1 year
Major Adverse Cardiac Events (MACE)
Time Frame: 1 year
Safety: Major Adverse Cardiac Events (MACE) at 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic Substudy
Time Frame: 9 months
QCA late loss
9 months
Optical Coherence Tomography (OCT) Substudy
Time Frame: 3 and 6 months
Stent struts coverage by intravascular OCT
3 and 6 months

Collaborators and Investigators

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

Sponsor

Fundacion Investigacion Interhospitalaria Cardiovascular

Collaborators

Effice Servicios Para la Investigacion S.L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

June 29, 2016

Primary Completion (ACTUAL)

January 28, 2020

Study Completion (ACTUAL)

March 31, 2020

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (ACTUAL)

August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEBSI-2

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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