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COMPLETEDNCT03606629

SOLARIS Endoprosthesis in Iliac Occlusive Disease

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.

Lead sponsor: Scitech Produtos Medicos SA•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Scitech Produtos Medicos SA

Age

18 - No limit years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 10, 2022Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment5

Start dateMar 2019

Last updatedMay 10, 2022

Condition

Peripheral Arterial Disease

Locations shown

Hospital de Clínicas de Passo Fundo

Passo Fundo, Rio Grande do Sul

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2022Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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