Acute Myocardial InfarctionPEBSI-2NCT03610347
Paclitaxel Eluting Balloon After Bare Metal Stent Implantation vs. Drug-Eluting Stent in St Elevation Myocardial Infarction
A study testing Bare metal Stent plus Paclitaxel Balloon and Drug Eluting Stent in people with Acute Myocardial Infarction, run by Fundacion Investigacion Interhospitalaria Cardiovascular at 16 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Bare metal Stent plus Paclitaxel Balloon and Drug Eluting Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 16 sitesSpain
- Study dates
- 29 Jun 2016to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 20Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Spain16 sites
Complejo Hospitalario U. de Albacete
Albacete, 05200
H. del Mar
Barcelona, 08003
H. U. Vall D'Hebron
Barcelona, 08035
H. Clínic
Barcelona, 08036
H. General U. de Ciudad Real
Ciudad Real, 13005
H. U. Virgen de las Nieves
Granada, 18014
H. U. de Bellvitge
L'Hospitalet de Llobregat, H. U. de Bellvitge, 08907
H. U. de La Princesa
Madrid, 28006
H. Clínico San Carlos
Madrid, 28040
H. U. 12 de Octubre
Madrid, 28041
H. U. Puerta de Hierro Majadahonda
Madrid, 28222
H. Regional U. de Málaga
Málaga, 29011
H. U. Son Espases
Palma de Mallorca, Balearic Islands, 07120
H. U. Puerto Real
Puerto Real, Cádiz, 11510
H. U. i Politècnic La Fe de Valencia
Valencia, 46026
H. Clínico U. de Valladolid
Valladolid, 47003
About this study
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 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.
Read the 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
- Being tested
- Bare metal Stent plus Paclitaxel Balloon, Drug Eluting Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bare metal Stent plus Paclitaxel BalloonDevice
Drug Eluting StentDevice
| Study group | Role | What they receive |
|---|---|---|
| Bare metal Stent plus Paclitaxel Balloon | Experimental | Conventional bare metal Stent plus Paclitaxel Eluting Balloon(Pantera Lux®) Receives: Device: Bare metal Stent plus Paclitaxel Balloon |
| Drug-Eluting Stent (DES) | Active comparator | Sirolimus Eluting Stent (Orsiro®) Receives: Device: Drug Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF)
Efficacy: TVF define as a the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization
Measured: 1 year
Secondary outcomes (2)
Target Lesion Revascularization (TLR)
Efficacy: ischemia-driven target-lesion revascularization
Measured: 1 year
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start29 Jun 2016
- Primary completion28 Jan 2020
- Study completion31 Mar 2020
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Sponsor type
- University, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Principal investigator, Arturo García-Touchard, Fundacion Investigacion Interhospitalaria Cardiovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610347
- Sponsor's protocol ID
- PEBSI-2
- Acronym
- PEBSI-2
- Status last verified
- May 2020
- First submitted
- 26 Jul 2018
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33826537
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03610347
- Acronym / sponsor ID
- PEBSI-2 / PEBSI-2
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Fundacion Investigacion Interhospitalaria CardiovascularUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bare metal Stent plus Paclitaxel Balloon | Experimental | Device: Bare metal Stent plus Paclitaxel BalloonConventional bare metal Stent plus Paclitaxel Eluting Balloon(Pantera Lux®) |
| Drug-Eluting Stent (DES) | Active comparator | Device: Drug Eluting StentSirolimus Eluting Stent (Orsiro®) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
- Women at childbearing age, where there is the possibility of pregnancy during the first year of follow-up, or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bare metal Stent plus Paclitaxel Balloon | Device | Bare metal Stent plus Paclitaxel Balloon |
| Drug Eluting Stent | Device | Drug-Eluting Stent (DES) |
Primary outcome
Target Vessel Failure (TVF)
Time frame: 1 year
Efficacy: TVF define as a the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization
2 secondary outcomes
Target Lesion Revascularization (TLR)
Time frame: 1 year
Major Adverse Cardiac Events (MACE)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Derived from this study: PubMed 33826537Garcia-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bare metal Stent plus Paclitaxel Balloon and Drug Eluting Stent in people with Acute Myocardial Infarction, run by Fundacion Investigacion Interhospitalaria Cardiovascular at 16 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure (TVF) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03610347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.