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

NCT ID: NCT03610347

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-29
• Study Completion Date: 2020-03-31

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.

Detailed Description

This is a multicenter, prospective, randomized, open study

After the permeabilization of the clinical event responsible artery patients will be randomized in a 1:1 ratio to one of the following treatment groups:

Group 1: insertion of a bare metal stent with post-dilatation with a paclitaxel eluting balloon (Pantera Lux ®)

Group 2: insertion of a drug elution stent

Patients (or their legal representative) must sign the consent before randomization.

Patients will be monitored 30 days after surgery, at 6 and 12 months.

The primary efficacy endpoint is Target Vessel Failure (TVF) at 12 months

This study will involve patients over 18 years old with STEMI, or new left bundle branch block or posterior AMI (ECG) that occur within 12 hours of onset of symptoms.

A total of 516 patients will be included.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• 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

Drug-Eluting Stent (DES)

Sirolimus Eluting Stent (Orsiro®)

Group Type: ACTIVE_COMPARATOR

Drug Eluting Stent

Intervention Type: DEVICE

Interventions

Bare metal Stent plus Paclitaxel Balloon

Intervention Type: DEVICE

Drug Eluting Stent

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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)
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Effice Servicios Para la Investigacion S.L.

INDUSTRY

Sponsor Role: collaborator

Fundacion Investigacion Interhospitalaria Cardiovascular

OTHER

Sponsor Role: lead

Responsible Party

Arturo García-Touchard

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

H. U. Son Espases

Palma de Mallorca, Balearic Islands, Spain

H. U. Puerto Real

Puerto Real, Cádiz, Spain

H. U. de Bellvitge

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

Complejo Hospitalario U. de Albacete

Albacete, , Spain

H. del Mar

Barcelona, , Spain

H. U. Vall D'Hebron

Barcelona, , Spain

H. Clínic

Barcelona, , Spain

H. General U. de Ciudad Real

Ciudad Real, , Spain

H. U. Virgen de las Nieves

Granada, , Spain

H. U. de La Princesa

Madrid, , Spain

H. Clínico San Carlos

Madrid, , Spain

H. U. 12 de Octubre

Madrid, , Spain

H. U. Puerta de Hierro Majadahonda

Madrid, , Spain

H. Regional U. de Málaga

Málaga, , Spain

H. U. i Politècnic La Fe de Valencia

Valencia, , Spain

H. Clínico U. de Valladolid

Valladolid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 33826537 (View on PubMed)

Other Identifiers

PEBSI-2

Identifier Type: -

Identifier Source: org_study_id