NCT01839890

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 6, 2015

Status Verified

July 1, 2014

Enrollment Period

2.2 years

First QC Date

March 26, 2013

Last Update Submit

February 5, 2015

Conditions

Acute Myocardial Infarction

Keywords

PaclitaxelstentAcute infarctionSystolic time elevation

Outcome Measures

Primary Outcomes (1)

  • Late Luminal Loss

    Loss measured in millimeters of late luminal space in vessels

    1 year

Secondary Outcomes (2)

  • Efficacy

    1 year

  • Safety

    1 year

Study Arms (2)

Bare metal Stent plus Paclitaxel Balloon

EXPERIMENTAL

Conventional bare metal Stent plus Paclitaxel Eluting Balloon(Pantera Lux)®

Device: Bare metal Stent plus Paclitaxel Balloon

Bare metal Stent

ACTIVE COMPARATOR

Conventional Bare Stent

Device: Bare metal Stent

Interventions

Bare metal Stent plus Paclitaxel BalloonDEVICE

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

Also known as: Balloon PANTERA LUX (R)
Bare metal Stent plus Paclitaxel Balloon
Bare metal StentDEVICE

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

Also known as: PROKINETIC ENERGY (R)
Bare metal Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Complexo Hospitalario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital General Universitario de Albacete

Albacete, Albacete, 02006, Spain

Location

H. Regional Universitario Infanta Cristina

Badajoz, Badajoz, 06006, Spain

Location

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Universitario Valle de Hebrón

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial

Barcelona, Barcelona, 08036, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, Cáceres, 10003, Spain

Location

Hospital Universitario Puerto Real

Puerto Real, Cádiz, 11510, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18012, Spain

Location

Hospital Arnau de Vilanova

Lleida, Lleida, 25198, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, Málaga, 29010, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41071, Spain

Location

Hospital Galdakao-Usanso

Galdakao, Vizcaya, 48960, Spain

Location

Related Publications (1)

  • Garcia-Touchard A, Sabate M, Gonzalo N, Peral V, Vaquerizo B, Ruiz-Salmeron R, Garcia Del Blanco B, Jimenez-Mazuecos J, Molina E, Martinez-Romero P, Hernandez-Garcia JM, Ruiz-Quevedo V, Urbano C, Fernandez-Portales J, Rumoroso JR, Casanova-Sandoval J, Pinar E, Lopez-Pais J, Oteo JF, Alfonso F. Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction: 8-year results of a randomized clinical trial (PEBSI study). Cardiovasc Diagn Ther. 2023 Oct 31;13(5):792-804. doi: 10.21037/cdt-22-623. Epub 2023 Oct 17.

    PMID: 37941845DERIVED

Study Officials

  • Francisco J. Goicolea, PhD

    Hospital Universitario Puerta de Hierro. Majadahonda. Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Fco. Javier Goicolea

Study Record Dates

First Submitted

March 26, 2013

First Posted

April 25, 2013

Study Start

April 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 6, 2015

Record last verified: 2014-07

Locations

ES(19)