Paclitaxel Eluting Balloon After Bare Metal Stent Implantation vs. Drug-Eluting Stent in St Elevation Myocardial Infarction

NCT03610347 | Terminated

• 1 other identifier: PEBSI-2
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 16

Brief Summary

Study objective is the evaluation of safety and efficacy at 12 months of the combination treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs drug eluting stent in patients with ST-elevation myocardial infarction with less than 12 hours of evolution.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure (TVF)

  Efficacy: TVF define as a the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization

  1 year

Secondary Outcomes (2)

• Target Lesion Revascularization (TLR)

  1 year

• Major Adverse Cardiac Events (MACE)

  1 year

Other Outcomes (2)

• Angiographic Substudy

  9 months

• Optical Coherence Tomography (OCT) Substudy

  3 and 6 months

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

Drug-Eluting Stent (DES)

ACTIVE COMPARATOR

Sirolimus Eluting Stent (Orsiro®)

Device: Drug Eluting Stent

Interventions

Bare metal Stent plus Paclitaxel Balloon DEVICE

Bare metal Stent plus Paclitaxel Balloon

Drug Eluting Stent DEVICE

Drug-Eluting Stent (DES)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged equal or older 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 85-100% stenosis and TIMI Score (Thrombolysis In Myocardial Infarction) of 0-I.

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)
• 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.

Sponsors & Collaborators

• Fundacion Investigacion Interhospitalaria Cardiovascular: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (16)

H. U. Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

H. U. Puerto Real

Puerto Real, Cádiz, 11510, Spain

Location

H. U. de Bellvitge

L'Hospitalet de Llobregat, H. U. de Bellvitge, 08907, Spain

Location

Complejo Hospitalario U. de Albacete

Albacete, 05200, Spain

Location

H. del Mar

Barcelona, 08003, Spain

Location

H. U. Vall D'Hebron

Barcelona, 08035, Spain

Location

H. Clínic

Barcelona, 08036, Spain

Location

H. General U. de Ciudad Real

Ciudad Real, 13005, Spain

Location

H. U. Virgen de las Nieves

Granada, 18014, Spain

Location

H. U. de La Princesa

Madrid, 28006, Spain

Location

H. Clínico San Carlos

Madrid, 28040, Spain

Location

H. U. 12 de Octubre

Madrid, 28041, Spain

Location

H. U. Puerta de Hierro Majadahonda

Madrid, 28222, Spain

Location

H. Regional U. de Málaga

Málaga, 29011, Spain

Location

H. U. i Politècnic La Fe de Valencia

Valencia, 46026, Spain

Location

H. Clínico U. de Valladolid

Valladolid, 47003, Spain

Location

Related Publications (1)

• Garcia-Touchard A, Gonzalo N, Goicolea J, Gomez-Lara J, Martin-Yuste V, Peral V, Martinez-Romero P, Vaquerizo B, Sanchez-Recalde A, Sarnago F, Oteo JF, Alfonso F. Early coronary healing in ST segment elevation myocardial infarction: sirolimus-eluting stents vs. drug-coated balloons after bare-metal stents. The PEBSI-2 optical coherence tomography randomized study. Coron Artery Dis. 2021 Dec 1;32(8):673-680. doi: 10.1097/MCA.0000000000001038.

  PMID: 33826537 DERIVED

MeSH Terms

Interventions

Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 1, 2018
• Study Start: June 29, 2016
• Primary Completion: January 28, 2020
• Study Completion: March 31, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Locations

ES (16)