SOLARIS Endoprosthesis in Iliac Occlusive Disease

Scitech Produtos Medicos SA5 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Endoprosthesis implantationDEVICE

Endoprosthesis implantation by Percutaneous Angioplasty

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital de Clínicas de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Major Adverse Events

MAE is defined as death related to study device/ procedure, Myocardial Infarction, Target Vessel Revascularization or member amputation

Time frame: 1 day

Target Lesion Patency

Stenosis \< 50% and systolic velocity up to 2.5 cm2/s and no TLR

Time frame: 6 months

Data from ClinicalTrials.gov

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