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Acute Myocardial InfarctionPhase 3PEBSI-01NCT01839890

Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction

A Phase 3 study testing Bare metal Stent plus Paclitaxel Balloon and Bare metal Stent in people with Acute Myocardial Infarction, run by Francisco Javier Goicolea at 19 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Bare metal Stent plus Paclitaxel Balloon and Bare metal Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
19 sitesSpain
Study dates
Apr 2012to Jun 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 22Show fewer
  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Spain19 sites

  • Hospital General Universitario de Albacete

    Albacete, Albacete, 02006

  • H. Regional Universitario Infanta Cristina

    Badajoz, Badajoz, 06006

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital Universitario Valle de Hebrón

    Barcelona, Barcelona, 08035

  • Hospital Clinic i Provincial

    Barcelona, Barcelona, 08036

  • Hospital San Pedro de Alcantara

    Cáceres, Cáceres, 10003

  • Hospital Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital Galdakao-Usanso

    Galdakao, Vizcaya, 48960

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada, 18012

  • Hospital Arnau de Vilanova

    Lleida, Lleida, 25198

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

  • Hospital Regional Universitario Carlos Haya

    Málaga, Málaga, 29010

  • Hospital Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Puerto Real

    Puerto Real, Cádiz, 11510

  • Complexo Hospitalario de Santiago

    Santiago de Compostela, A Coruña, 15706

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41071

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Bare metal Stent plus Paclitaxel Balloon, Bare metal Stent
Keywords
Paclitaxel, stent, Acute infarction, Systolic time elevation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bare metal Stent plus Paclitaxel BalloonDevice

    Also called Balloon PANTERA LUX (R)

    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

  • Bare metal StentDevice

    Also called PROKINETIC ENERGY (R)

    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

Study groups in NCT01839890
Study groupRoleWhat they receive
Bare metal Stent plus Paclitaxel BalloonExperimentalConventional bare metal Stent plus Paclitaxel Eluting Balloon(Pantera Lux)®
Receives: Device: Bare metal Stent plus Paclitaxel Balloon
Bare metal StentActive comparatorConventional Bare Stent
Receives: Device: Bare metal Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late Luminal Loss

    Loss measured in millimeters of late luminal space in vessels

    Measured: 1 year

Secondary outcomes (2)

  1. Efficacy

    Efficacy: angiography restenosis, minimal luminal diameter, ischemia directed target vessel revascularization (TVR), MACE (death, infarction, TVR)

    Measured: 1 year

  2. Safety

    Safety: MACE/ month, at 6 months and 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2013 (estimated)
  2. Study startApr 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839890
Sponsor's protocol ID
PEBSI-01
Acronym
PEBSI-01
Status last verified
Jul 2014
First submitted
26 Mar 2013
Last updated
6 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37941845

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bare metal Stent plus Paclitaxel Balloon and Bare metal Stent in people with Acute Myocardial Infarction, run by Francisco Javier Goicolea at 19 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late Luminal Loss (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01839890, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.

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