Patients with diagnosis of lower limbs PAOD, ranging from stage 2 to 5 according to Rutherford classification and lesions of the SFA treated by endovascular revascularization MedDRA version: 20.0 Level: LLT Classification code 10016430 Term: Femoral artery stenosis System Organ Class: 100000004866
Conditions
Interventions
Trade Name: ACIDO ACETILSALICILICO MYLAN - 100 MG COMPRESSE GASTRORESISTENTI 20 COMPRESSE IN BLISTER AL/AL
Product Name: Acido acetilsalicilico
Product Code: [Acido acetilsalicilico]
Pharmaceutical Fo
Sponsors
FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Have given written informed consent to participate • Be aged 18 years and over • Be affected by lower limbs PAOD staged 2-5 according to Rutherford classification and lesions of the SFA • Have undergone a successful endovascular revascularization of the SFA as documented by the intra-operative angiography Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: -Life expectancy 15 mg per week) -Participants to a clinical trial consisting in administration of an experimental drug within 30 days or 5 half-lives of the drug under investigation. -Patients under anticoagulant therapy -History of allergies to ASA and/or clopidogrel -Lack of written informed consent by the patients -Unwillingness, impossibility or incapability to respect the study protocol for any reason -CKF under haemodialytic treatment, because it can affect the patency rate of the lumen bias the results on such a small-sized sample) -Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess and quantify the efficacy of benefits in terms of patency rate of the target lesion (Late Lumen Loss) 3, 6 and 12 months after the procedure of revascularization across the two branches;Secondary Objective: To assess and compare the rate of adverse events (bleeding) related to DAPT with the short regime as compared with the prolonged regime. (b) To assess and compare the need of Target Lesion Revascularization at 3, 6 and 12 months. (c) To quantify and compare the major amputation-free survival at 12 months;Primary end point(s): Late Lumen Loss (LLL), defined as difference between the lumen diameter of the target artery measured right after the procedure of revascularization and after 3, 6 and 12 months;Timepoint(s) of evaluation of this end point: after the procedure di revascularization and after 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (a). Prevalence of bleeding episodes. (b) Need of Target Lesion Revascularization (TLR) assessed 3, 6 and 12 months after the revascularization. The expected value of TLR after 12 months from the literature analysis is 25%. (c) Major amputation-free survival at 12 months after the revascularization (expected value: 85-90%);Timepoint(s) of evaluation of this end point: (b) 3, 6 and 12 months after the rivascularization (c) 12 months after the rivascularization | — |
Countries
Italy
Contacts
Public ContactU.O.C. CHIRURGIA VASCOLARE
FONDAZIONE IRCCS POLICLINICO SAN MATTEO
Outcome results
None listed