Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— PEBSI-01  

Official title:

Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction After Bare Metal Stent Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839890
• Other study ID #: PEBSI-01
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2013
• Last updated: February 5, 2015
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Albacete	Albacete
Spain	H. Regional Universitario Infanta Cristina	Badajoz
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Valle de Hebrón	Barcelona
Spain	Hospital San Pedro de Alcantara	Cáceres
Spain	Hospital Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Galdakao-Usanso	Galdakao	Vizcaya
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Clínico Universitario Virgen de la Victoria	Málaga
Spain	Hospital Regional Universitario Carlos Haya	Málaga
Spain	Hospital Son Espases	Palma de Mallorca	Islas Baleares
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Puerto Real	Puerto Real	Cádiz
Spain	Complexo Hospitalario de Santiago	Santiago de Compostela	A Coruña
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Francisco Javier Goicolea	Effice Servicios Para la Investigacion S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late Luminal Loss	Loss measured in millimeters of late luminal space in vessels	1 year	No
Secondary	Efficacy	Efficacy: angiography restenosis, minimal luminal diameter, ischemia directed target vessel revascularization (TVR), MACE (death, infarction, TVR)	1 year	Yes
Secondary	Safety	Safety: MACE/ month, at 6 months and 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).	1 year	Yes