Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction (PEBSI-01)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Effice Servicios Para la Investigacion S.L.
Information provided by (Responsible Party):
Francisco Javier Goicolea, Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
ClinicalTrials.gov Identifier:
NCT01839890
First received: March 26, 2013
Last updated: February 24, 2014
Last verified: February 2014

March 26, 2013
February 24, 2014
April 2012
October 2014   (final data collection date for primary outcome measure)
Late Luminal Loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Loss measured in millimeters of late luminal space in vessels
Late Luminal Loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Loss measured in milimeters of late luminal space in vessels
Complete list of historical versions of study NCT01839890 on ClinicalTrials.gov Archive Site
  • Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Efficacy: angiography restenosis, minimal luminal diameter, ischemia directed target vessel revascularization (TVR), MACE (death, infarction, TVR)
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Safety: MACE/ month, at 6 months and 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).
  • Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Efficacy: angiography restenosis, minimal luminal diameter, ischemia directed target vessel revascularization (TVR), MACE (death, infarction, TVR)
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Safety: MACE/ month, at 6 months and 12 months (death, re-infarction, ACV, hemorrhagy and/or stent thrombosis).
Not Provided
Not Provided
 
Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction
Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction After Bare Metal Stent Insertion

Study objective is the evaluation of safety and efficacy at 9 months of combination treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs bare metal stent (conventional treatment) in patients with acute myocardial infarction with systolic time elevation of less than 12 hours of evolution.

This is a multicenter, prospective, randomized, open study

After the permeabilization of the clinical event responsible artery and the insertion of a bare metal stent, patients will be randomized in a 1:1 ratio to one of the following treatment groups:

Group 1: post-dilatation with a paclitaxel eluting balloon (Pantera Lux ®) Group 2: no post-dilatation Patients (or their legal representative) must sign the consent before randomization.

After surgery, patients will be treated with dual antiplatelet therapy (aspirin plus clopidogrel) for at least one month to group 2 patients; and at least 3 months in those who are also treated with the paclitaxel eluting balloon (group 1). Aspirin is prescribed indefinitely according to the usual practice in these patients.

Patients will be monitored 30 days after surgery, at 6 and 12 months, and the ninth month (in which patient will receive an angiographic control).

The primary efficacy endpoint is late lumen loss (PLT) comparing it value during surgery and control angiography at 9 months

This study will involve patients over 18 years olds with systolic time elevation myocardial infarction, or new left bundle branch block or posterior AMI (ECG) that occur within 12 hours of onset of symptoms to treatment by primary angioplasty.

They include a total of 220 patients.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Acute Myocardial Infarction
  • Device: Bare metal Stent plus Paclitaxel Balloon
    After the permeabilization of the clinical event responsible artery with conventional therapy (including the insertion of a conventional metal stent and once by the interventional cardiologist gives good final result), patients will be randomized in a 1:1 ratio
    Other Name: Balloon PANTERA LUX (R)
  • Device: Bare metal Stent
    After the permeabilization of the clinical event responsible artery with conventional therapy a conventional metal stent will be inserted. Once by the interventional cardiologist gives good final result), patients will be randomized in a 1:1 ratio
    Other Name: PROKINETIC ENERGY (R)
  • Experimental: Bare metal Stent plus Paclitaxel Balloon
    Conventional bare metal Stent plus Paclitaxel Eluting Balloon(Pantera Lux)®
    Intervention: Device: Bare metal Stent plus Paclitaxel Balloon
  • Active Comparator: Bare metal Stent
    Conventional Bare Stent
    Intervention: Device: Bare metal Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged less 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 90-100% stenosis.

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)
    • Reference vessel diameter less than 2.5 mm and greater than 4 mm (larger ball)
    • 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.
  • Cases in which is indicated bypass surgery within 30 days after infarction.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01839890
PEBSI-01
No
Francisco Javier Goicolea, Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Francisco Javier Goicolea
Effice Servicios Para la Investigacion S.L.
Study Director: Francisco J. Goicolea, PhD Hospital Universitario Puerta de Hierro. Majadahonda. Madrid
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP