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Paclitaxel Eluting Balloon After Bare Metal Stent Implantation vs. Drug-Eluting Stent in St Elevation Myocardial Infarction (PEBSI-2)

Primary Purpose

Acute Myocardial Infarction

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Bare metal Stent plus Paclitaxel Balloon
Drug Eluting Stent
Sponsored by
Fundacion Investigacion Interhospitalaria Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • H. U. Son Espases
  • H. U. Puerto Real
  • H. U. de Bellvitge
  • Complejo Hospitalario U. de Albacete
  • H. del Mar
  • H. U. Vall D'Hebron
  • H. Clínic
  • H. General U. de Ciudad Real
  • H. U. Virgen de las Nieves
  • H. U. de La Princesa
  • H. Clínico San Carlos
  • H. U. 12 de Octubre
  • H. U. Puerta de Hierro Majadahonda
  • H. Regional U. de Málaga
  • H. U. i Politècnic La Fe de Valencia
  • H. Clínico U. de Valladolid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bare metal Stent plus Paclitaxel Balloon

Drug-Eluting Stent (DES)

Arm Description

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

Sirolimus Eluting Stent (Orsiro®)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Target Lesion Revascularization (TLR)
Efficacy: ischemia-driven target-lesion revascularization
Major Adverse Cardiac Events (MACE)
Safety: Major Adverse Cardiac Events (MACE) at 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).

Full Information

First Posted
July 26, 2018
Last Updated
May 21, 2020
Sponsor
Fundacion Investigacion Interhospitalaria Cardiovascular
Collaborators
Effice Servicios Para la Investigacion S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT03610347
Brief Title
Paclitaxel Eluting Balloon After Bare Metal Stent Implantation vs. Drug-Eluting Stent in St Elevation Myocardial Infarction
Acronym
PEBSI-2
Official Title
Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon After Bare Metal Stent Implantation Versus Drug-eluting Stent in St Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
June 29, 2016 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Investigacion Interhospitalaria Cardiovascular
Collaborators
Effice Servicios Para la Investigacion S.L.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bare metal Stent plus Paclitaxel Balloon
Arm Type
Experimental
Arm Description
Conventional bare metal Stent plus Paclitaxel Eluting Balloon(Pantera Lux®)
Arm Title
Drug-Eluting Stent (DES)
Arm Type
Active Comparator
Arm Description
Sirolimus Eluting Stent (Orsiro®)
Intervention Type
Device
Intervention Name(s)
Bare metal Stent plus Paclitaxel Balloon
Intervention Type
Device
Intervention Name(s)
Drug Eluting Stent
Primary Outcome Measure Information:
Title
Target Vessel Failure (TVF)
Description
Efficacy: TVF define as a the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Target Lesion Revascularization (TLR)
Description
Efficacy: ischemia-driven target-lesion revascularization
Time Frame
1 year
Title
Major Adverse Cardiac Events (MACE)
Description
Safety: Major Adverse Cardiac Events (MACE) at 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Angiographic Substudy
Description
QCA late loss
Time Frame
9 months
Title
Optical Coherence Tomography (OCT) Substudy
Description
Stent struts coverage by intravascular OCT
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
H. U. Son Espases
City
Palma De Mallorca
State/Province
Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
H. U. Puerto Real
City
Puerto Real
State/Province
Cádiz
ZIP/Postal Code
11510
Country
Spain
Facility Name
H. U. de Bellvitge
City
L'Hospitalet De Llobregat
State/Province
H. U. De Bellvitge
ZIP/Postal Code
08907
Country
Spain
Facility Name
Complejo Hospitalario U. de Albacete
City
Albacete
ZIP/Postal Code
05200
Country
Spain
Facility Name
H. del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
H. U. Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
H. Clínic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
H. General U. de Ciudad Real
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Facility Name
H. U. Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
H. U. de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
H. Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
H. U. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
H. U. Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
H. Regional U. de Málaga
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
H. U. i Politècnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
H. Clínico U. de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33826537
Citation
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.
Results Reference
derived

Learn more about this trial

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

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