Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction

Phase 3

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Device: Bare metal Stent; Device: Bare metal Stent plus Paclitaxel Balloon

• Registration Number: NCT01839890
• Lead Sponsor: Francisco Javier Goicolea

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2015-02-05
• Last Update Posted: 2015-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bare metal Stent	Bare metal Stent	Conventional Bare Stent
Bare metal Stent plus Paclitaxel Balloon	Bare metal Stent plus Paclitaxel Balloon	Conventional bare metal Stent plus Paclitaxel Eluting Balloon(Pantera Lux)®

Primary Outcome Measures

Name	Time	Method
Late Luminal Loss	1 year	Loss measured in millimeters of late luminal space in vessels

Secondary Outcome Measures

Name	Time	Method
Efficacy	1 year	Efficacy: angiography restenosis, minimal luminal diameter, ischemia directed target vessel revascularization (TVR), MACE (death, infarction, TVR)
Safety	1 year	Safety: MACE/ month, at 6 months and 12 months (death, re-infarction, acute cardiovascular disease, hemorrhagy and/or stent thrombosis).

Trial Locations

Locations (19)

Complexo Hospitalario de Santiago; 🇪🇸 Santiago de Compostela, A Coruña, Spain

Hospital Universitario Puerto Real; 🇪🇸 Puerto Real, Cádiz, Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Islas Baleares, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain

Hospital Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Galdakao-Usanso; 🇪🇸 Galdakao, Vizcaya, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital General Universitario de Albacete; 🇪🇸 Albacete, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Clinic i Provincial; 🇪🇸 Barcelona, Spain

H. Regional Universitario Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital San Pedro de Alcantara; 🇪🇸 Cáceres, Spain

Hospital Universitario Valle de Hebrón; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain

Hospital Clínico Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Regional Universitario Carlos Haya; 🇪🇸 Málaga, Spain