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

Acute Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03610347
• Other study ID #: PEBSI-2
• Status: Terminated
• Phase: N/A
• Start date: June 29, 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: Fundacion Investigacion Interhospitalaria Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 199
• Est. completion date: March 31, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Device:
• Bare metal Stent plus Paclitaxel Balloon

• Drug Eluting Stent

Locations

Country	Name	City	State
Spain	Complejo Hospitalario U. de Albacete	Albacete
Spain	H. Clínic	Barcelona
Spain	H. del Mar	Barcelona
Spain	H. U. Vall D'Hebron	Barcelona
Spain	H. General U. de Ciudad Real	Ciudad Real
Spain	H. U. Virgen de las Nieves	Granada
Spain	H. U. de Bellvitge	L'Hospitalet De Llobregat	H. U. De Bellvitge
Spain	H. Clínico San Carlos	Madrid
Spain	H. U. 12 de Octubre	Madrid
Spain	H. U. de La Princesa	Madrid
Spain	H. U. Puerta de Hierro Majadahonda	Madrid
Spain	H. Regional U. de Málaga	Málaga
Spain	H. U. Son Espases	Palma De Mallorca	Baleares
Spain	H. U. Puerto Real	Puerto Real	Cádiz
Spain	H. U. i Politècnic La Fe de Valencia	Valencia
Spain	H. Clínico U. de Valladolid	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion Investigacion Interhospitalaria Cardiovascular	Effice Servicios Para la Investigacion S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Angiographic Substudy	QCA late loss	9 months
Other	Optical Coherence Tomography (OCT) Substudy	Stent struts coverage by intravascular OCT	3 and 6 months
Primary	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	Target Lesion Revascularization (TLR)	Efficacy: ischemia-driven target-lesion revascularization	1 year
Secondary	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).	1 year