Will be enrolled in the study patients suffering from intermittent claudication in whom resulted ineffective both pharmacological and workout therapy- Will be considered eligible patients aged 40-80 inclusive, with an ankle-brachial index (ABI) 1.3 at basal condition and diametrical arterial stenosis equal or superior to 50% vessel lumen, undergoing peripheral revascularization procedures. MedDRA version: 14.1 Level: LLT Classification code 10003209 Term: Arteriopathy System Organ Class: 10047
Conditions
Sponsors
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Intermittent claudication affected patients in whom resulted ineffective both pharmacological and workout therapy; Both gender aged 40-80 inclusive; ABI 1.3; Diametrical arterial stenosis equal or superior to 50% vessel lumen. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 205 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 205
Exclusion criteria
Exclusion criteria: Critical or acute limb ischemia affected patients; Patients underwent a previous revascularization procedure within 6 months to the enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate antiplatelet treatment resistance percentage, considering the residual platelet activity as superior to 70% using ADP or Arachidonic Acid in vitro aggregation tests.;Secondary Objective: To compare different platelet function test about sensitivity, specificity and future clinical events predictive values; To evaluate the relationship between oxidative stress indexes and platelet activation; To evaluate the antiplatelet treatment resistance role on future clinical events; To evaluate the platelet fuction test predictive role, seric thromboxane levels and oxidative stress indexes levels on future clinical events; To validate a both clinical and laboratory predicitive score to identify the recurrent thrombosis high risk patients; To verify the platelet function tests diffusion in the real world.;Primary end point(s): The target vessels thrombosis absence.;Timepoint(s) of evaluation of this end point: 30 days, 3 months, 6 months, 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The occurrence of a Major Adverse Cardiac Events.;Timepoint(s) of evaluation of this end point: 30 days, 3 months, 6 months, 12 months. | — |
Countries
Italy
Contacts
Public ContactUOC Medicina Interna C - TMC07
Sapienza - Universita' di Roma, Policlinico Umberto I°
Outcome results
None listed