SOLARIS Endoprosthesis in Iliac Occlusive Disease (SOLARIS I)

Scitech Produtos Medicos

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Endoprosthesis implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT03606629

SC-SO-001

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

5 participants in 1 patient group

Endoprosthesis implantation

Description:

Device implantation

Treatment:

Device: Endoprosthesis implantation