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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03610347
Recruitment Status : Terminated (Low recruitment)
First Posted : August 1, 2018
Last Update Posted : May 26, 2020
Sponsor:
Collaborator:
Effice Servicios Para la Investigacion S.L.
Information provided by (Responsible Party):
Arturo García-Touchard, Fundacion Investigacion Interhospitalaria Cardiovascular

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: Bare metal Stent plus Paclitaxel Balloon Device: Drug Eluting Stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 29, 2016
Actual Primary Completion Date : January 28, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Paclitaxel

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Target Lesion Revascularization (TLR) [ Time Frame: 1 year ]
    Efficacy: ischemia-driven target-lesion revascularization

  2. 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).


Other Outcome Measures:
  1. Angiographic Substudy [ Time Frame: 9 months ]
    QCA late loss

  2. Optical Coherence Tomography (OCT) Substudy [ Time Frame: 3 and 6 months ]
    Stent struts coverage by intravascular OCT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610347


Locations
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Spain
H. U. Son Espases
Palma De Mallorca, Baleares, Spain, 07120
H. U. Puerto Real
Puerto Real, Cádiz, Spain, 11510
H. U. de Bellvitge
L'Hospitalet De Llobregat, H. U. De Bellvitge, Spain, 08907
Complejo Hospitalario U. de Albacete
Albacete, Spain, 05200
H. del Mar
Barcelona, Spain, 08003
H. U. Vall D'Hebron
Barcelona, Spain, 08035
H. Clínic
Barcelona, Spain, 08036
H. General U. de Ciudad Real
Ciudad Real, Spain, 13005
H. U. Virgen de las Nieves
Granada, Spain, 18014
H. U. de La Princesa
Madrid, Spain, 28006
H. Clínico San Carlos
Madrid, Spain, 28040
H. U. 12 de Octubre
Madrid, Spain, 28041
H. U. Puerta de Hierro Majadahonda
Madrid, Spain, 28222
H. Regional U. de Málaga
Málaga, Spain, 29011
H. U. i Politècnic La Fe de Valencia
Valencia, Spain, 46026
H. Clínico U. de Valladolid
Valladolid, Spain, 47003
Sponsors and Collaborators
Fundacion Investigacion Interhospitalaria Cardiovascular
Effice Servicios Para la Investigacion S.L.
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Responsible Party: Arturo García-Touchard, Principal Investigator, Fundacion Investigacion Interhospitalaria Cardiovascular
ClinicalTrials.gov Identifier: NCT03610347    
Other Study ID Numbers: PEBSI-2
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action