peripheral arterial disease
Conditions
Interventions
Trade Name: Brilique
Product Name: Ticagrelor
Pharmaceutical Form: Tablet
Sponsors
AUSL 8
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age > 18 years, with clinical evidence of claudication or critical limb ischemia; angiographic evidence of > 50% stenosis or occlusion of the superficial femoral or popliteal artery for a length > 40mm; presence of at least 1 vessel with direct flow to the pedal circle; treated with drug eluting stent implantation 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: need of major limb amputation for irreversibility of the lesions (judged by diabetic foot specialist); hypersensitivity or known contraindications to aspirin, heparin, ticagrelor or paclitaxel or any of the excipients; known hypersensitivity to iodinated contrast media that cannot be adequately controlled by premedication; unwillingness to carry out clinical and angiographic controls; patients with a medical condition requiring treatment with cytostatic drugs or radiation therapy with a life expectancy of less than 1 year; active pathological bleeding, history of intracranial haemorrhage and severe hepatic failure; pregnancy or lactation; dialysis required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study will be to evaluate the benefit of the administration of ticagrelor on intermediate endpoints of efficacy (% of neointimal volume obstruction) and safety (percentage of uncovered stent struts) assessed by Frequency Domain-Optical Coherence Tomography in patients with symptomatic femoropopliteal disease, mainly presenting with critical limb ischemia, and treated with angioplasty and implantation of paclitaxel-eluting stent(s).;Secondary Objective: Secondary endpoints will be 1) platelet function assay (using VerifyNow system) before intervention, at 24 hours, and at 1, 3,and 12 months 2) eventual presence; maximal area and total volume of instent thrombus, at baseline and follow-up 3) strut-level neointimal thickness 4) post-intervention and follow-up tissue prolapse and dissection 5) % of acute, persisting and newly acquired malapposed struts. Correlative studies between PRU and % net volume obstruction, % uncovered stent struts, and total thrombus area will be performed. A dedicated subanalysis will be performed in the stent overlap areas;Primary end point(s): net percentage volume obstruction assessed by Frequency-Domain -Optical Coherence Tomography;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) platelet function assay (using VerifyNow system) before intervention, at 24 hours, and at 1, 3,and 12 months 2) eventual presence; maximal area and total volume of instent thrombus, at baseline and follow-up 3) strut-level neointimal thickness 4) post-intervention and follow-up tissue prolapse and dissection 5) % of acute, persisting and newly acquired malapposed struts. Correlative studies between PRU and % net volume obstruction, % uncovered stent struts, and total thrombus area will be performed. A dedicated subanalysis will be performed in the stent overlap areas;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactMalattie Cardiovascolari
AUSL8
Outcome results
None listed