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

This study has been completed.
Sponsor:
Collaborator:
Effice Servicios Para la Investigacion S.L.
Information provided by (Responsible Party):
Francisco Javier Goicolea, Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
ClinicalTrials.gov Identifier:
NCT01839890
First received: March 26, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Device: Bare metal Stent plus Paclitaxel Balloon
Device: Bare metal Stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction After Bare Metal Stent Insertion

Resource links provided by NLM:


Further study details as provided by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular:

Primary Outcome Measures:
  • Late Luminal Loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Loss measured in millimeters of late luminal space in vessels


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Efficacy: angiography restenosis, minimal luminal diameter, ischemia directed target vessel revascularization (TVR), MACE (death, infarction, TVR)

  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Safety: MACE/ month, at 6 months and 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).


Enrollment: 202
Study Start Date: April 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: PROKINETIC ENERGY (R)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839890

Locations
Spain
Complexo Hospitalario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Hospital Universitario Puerto Real
Puerto Real, Cádiz, Spain, 11510
Hospital Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07120
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Galdakao-Usanso
Galdakao, Vizcaya, Spain, 48960
Hospital General Universiario de Albacete
Albacete, Spain, 02006
H. Regional Universitario Infanta Cristina
Badajoz, Spain, 06006
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Valle de Hebrón
Barcelona, Spain, 08035
Hospital San Pedro de Alcantara
Cáceres, Spain, 10003
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18012
Hospital Arnau de Vilanova
Lleida, Spain, 25198
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Regional Universitario Carlos Haya
Málaga, Spain, 29010
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain, 29010
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41071
Sponsors and Collaborators
Francisco Javier Goicolea
Effice Servicios Para la Investigacion S.L.
Investigators
Study Director: Francisco J. Goicolea, PhD Hospital Universitario Puerta de Hierro. Majadahonda. Madrid
  More Information

No publications provided

Responsible Party: Francisco Javier Goicolea, Dr. Fco. Javier Goicolea, Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
ClinicalTrials.gov Identifier: NCT01839890     History of Changes
Other Study ID Numbers: PEBSI-01
Study First Received: March 26, 2013
Last Updated: July 9, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular:
Paclitaxel
stent
Acute infarction
Systolic time elevation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014