None listed
Conditions
Interventions
Group A Type of group
They will receive infusion of placebo (Dextrose 5% in water) for 30 minutes, immediately after the angioplasty will be performed applying a bolus of intraarterial heparin at the beginning of the cannulation of the artery to intervene, the necessary boluses will be repeated according to the requirements of the case and following the institutional guidelines.
Group name:Grupo B Type of group
Tirofiban will be administered through the intravenous cannula
an initial infusion of 10 mcg / Kg administered in 3 minutes, followed by a maintenance infusion of 0.15 mcg / Kg / min for 36 hours, immediately after applying the bolus of Tirofiban angioplasty will
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: All patients with a diagnosis of Fontain IIb peripheral obstructive arteriopathy, angiographic category 1, Aortoiliac and Iliofemoral sector, whose choice therapy following the international criteria applied in the institution, is the elective ATP, hospitalized in the 2BE of the HNGAI.
Exclusion criteria
Exclusion criteria: • Gestation or suspicion of it. • Contraindication of anticoagulation or increased risk of bleeding: • Recent active bleeding ( 180 mmHg and / or diastolic blood pressure> 110 Hg, at the time of entering the study. • History of hemorrhagic cerebrovascular disease or active intracranial pathological process (neoplasia, arteriovenous malformation or aneurysm). Any history of cerebrovascular disease in the last year (stroke or transient ischemic attack). • Trauma or prolonged cardiopulmonary resuscitation maneuvers in the last 2 weeks prior to the study. • Severe trauma in the last month prior to the study. • Major surgery, any ophthalmic surgery or biopsy in the month prior to the study. • Active ulceropeptic disease in the last 3 months prior to the study. • Acute pericarditis. • Presence of significant retinopathy (hemorrhagic or proliferative). • Thrombolytic therapy in the 48 hours prior to the study. • Treatment with Abciximab (ReoPro) or Eptifibatide (Integrilin) ​​14 days prior to the study. • Patients on chronic treatment with Ticlopidine or Clopidogrel, or who have received> = 500 mg of Ticlopidine or> 75 mg of Clopidogrel in the previous 48 hours. • Patients using Warfarin. • Patients under spinal / epidural anesthesia or spinal puncture (due to risk of epidural or spinal hematoma, which has caused neurological injury including: permanent / prolonged paralysis, or those receiving low molecular weight heparins). • Allergy or hypersensitivity to Tirofiban, Aspirin, • Heparin, low molecular weight heparin, or any component of these products. • Patients with severe cardiovascular disease who require urgent therapy • History or symptoms suggestive of aortic dissection (pain radiating to the back). • Patients with acute pulmonary edema (presence of rales in more than 50% of lung fields) or severe congestive heart failure (New York Heart Association, functional class III or IV). • Appearance of angina due to known precipitating factors (arrhythmia, infection, severe anemia, hyperthyroidism). • Patients with severe uncontrolled cardiac arrhythmia (leading to hemodynamic instability). • Systolic pressure <95mm Hg or cardiogenic shock at the time of study inclusion. • Presence of more than 50% of left cardiac injury not protected by bypass. • Patients with significant valvular disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease. • Patients with any medical condition, which, in the opinion of the investigators, presumes a survival incompatible with the duration of the study, interference with the participation in it or means a risk for the patient: • History of alcohol or other drug abuse. • Patients with a history of cancer except for basal cell carcinoma of the skin. • Patient with significant systemic failure: renal, hepatic, endocrine, neurological or hematologic. • Patient with important laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Baseline echo-Doppler (prior to the Procedure) and at 2, 7, and 30 days post-ATP Measure:Restenosis of the operated artery Timepoints:At 2, 7, and 30 days post-ATP | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Death, repeat of new ATP / Stent, surgical revascularization or amputation of the limb by: abrupt closure of the operated artery or by any other cause Measure:Death, repeat of new ATP / Stent, surgical revascularization or amputation of the limb by: abrupt closure of the operated artery or by any other cause at 2, 7, 30 and 90 days of the procedure Timepoints:At 2, 7, 30 and 90 days of the procedure ; Outcome name:major: hemorrhage that causes decrease in hemoglobin at> 5gr / dl and / or merits transfusion> 2 units of blood, or blood components; intracranial or intraperitoneal hemorrhage. minor: any one that does not meet the criteria of the previous section Measure:Hemorrhagic complication Timepoints:Evaluable intraprocedure, at 24 and 72 hours after ATP. | — |
Outcome results
None listed