Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction

NCT ID: NCT01839890

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-06-30

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.

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Bare metal Stent plus Paclitaxel Balloon

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

Group Type: EXPERIMENTAL

Bare metal Stent plus Paclitaxel Balloon

Intervention Type: DEVICE

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 Stent

Conventional Bare Stent

Group Type: ACTIVE_COMPARATOR

Bare metal Stent

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Balloon PANTERA LUX (R); PROKINETIC ENERGY (R)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Effice Servicios Para la Investigacion S.L.

INDUSTRY

Sponsor Role: collaborator

Francisco Javier Goicolea

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier Goicolea

Dr. Fco. Javier Goicolea

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francisco J. Goicolea, PhD

Role: STUDY_DIRECTOR

Hospital Universitario Puerta de Hierro. Majadahonda. Madrid

Locations

Complexo Hospitalario de Santiago

Santiago de Compostela, A Coruña, Spain

Hospital General Universitario de Albacete

Albacete, Albacete, Spain

H. Regional Universitario Infanta Cristina

Badajoz, Badajoz, Spain

Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Universitario Valle de Hebrón

Barcelona, Barcelona, Spain

Hospital Clinic i Provincial

Barcelona, Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Cáceres, Spain

Hospital Universitario Puerto Real

Puerto Real, Cádiz, Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Hospital Arnau de Vilanova

Lleida, Lleida, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital Regional Universitario Carlos Haya

Málaga, Málaga, Spain

Hospital de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Hospital Galdakao-Usanso

Galdakao, Vizcaya, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 37941845 (View on PubMed)

Other Identifiers

PEBSI-01

Identifier Type: -

Identifier Source: org_study_id