IMPACT ASSESSMENT OF ARTERIAL OCCLUSION AFTER TREATMENT WITH PENTOXIFYLLINE after angioplasty

Conditions: PERIPHERAL ARTERIOPATHY
MedDRA version: 14.1Level: SOCClassification code 10047065Term: Vascular disordersSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-000868-15-IT

Lead Sponsor: IVERSITA' CAMPUS BIOMEDICO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Age> 55 years
- Moderate to severe arterial disease stage (Stage IIb and III sec. Fontaine)
- walking capacity <150 m
- Hemodynamic stenosis (> 50% of restriction of the vessel lumen) at the superficial femoral artery
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Refusal of patients to participate in the study;
- Cognitive deterioration (MMSE <24).
- IRC severe (creatinine clearance <30 ml / minute)
- Arterial leg stage IV sec. Fontaine

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: the effectiveness of treatment with pentoxifylline;Secondary Objective: whether and how the outcome of treatment with pentoxifylline in the long term is not influenced by hemodynamic variables;Primary end point(s): - Test of the six-minute walk<br> - Percutaneous oximetry (electrodes positioned lower third leg, the middle third of leg and dorsum of the foot limb revascularized)<br> - Angio-MRI lower extremity<br> - Dynamometry segmental level of the quadriceps and gastrocnemius muscle of the limb revascularized;;Timepoint(s) of evaluation of this end point: one month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Evaluation of multidimensional (VMD) (which includes the MMSE, GDS, ADL, IADL)<br> - EPIC questionnaire (questionnaire which aims to investigate the relationships between diet, environmental factors and lifestyle, and incidence of cancer and other chronic diseases).<br> - PASE Questionnaire (questionnaire aims to assess the level of habitual physical activity of the patient)<br> - Percutaneous segmental Oximetry: electrode placed at the lower third of thigh, the middle third of leg and dorsum of the foot to revascularize the limb;<br> - Arterial blood gas analysis;<br> - Segmental Dynamometry: estimating the strength of three different measurements at the level of the quadriceps muscle and gastrocnemius muscle from revascularize the limb;;Timepoint(s) of evaluation of this end point: one month