Peripheral Arterial Disease
Conditions
Brief summary
Fifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.
Interventions
DEVICEEndoprosthesis implantation
Endoprosthesis implantation by Percutaneous Angioplasty
Sponsors
Scitech Produtos Medicos Ltda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rutherford Class 2 to 5; * Tasc II Class A, B, C or D; * Unilateral or bilateral lesion, de novo or restenotic but not in-stent; * Target lesion of 3 to 10 cm length; * ≥ 50% stenosis or common iliac or external iliac artery; * Reference vessel diameter ≥ 5 and ≤ 9 mm; * Deep femoral artery patent and at least one infrapopliteal artery patent; * Informed Consent provided.
Exclusion criteria
* Thrombocytopenia induced by heparina or tPA intravenous, clopidogrel, ticlopidine or aspirin sensitivity; * Target lesion near to aneurysm, highly calcified or excessively tortuous; * Previous stent on target vessel; * Presence of other lesions that need treatment within 30 days; * Rutherford Class 6; * Acute thrombotic occlusion; * History on amputation on the target limb.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | 1 day | MAE is defined as death related to study device/ procedure, Myocardial Infarction, Target Vessel Revascularization or member amputation |
| Target Lesion Patency | 6 months | Stenosis \< 50% and systolic velocity up to 2.5 cm2/s and no TLR |
Countries
Brazil
Outcome results
None listed