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OpenTrials
Completed

NCT Number: NCT03606629

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Clínicas de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoprosthesis implantation

Device

Endoprosthesis implantation by Percutaneous Angioplasty

Primary outcomes

  1. Major Adverse Events

    Time frame: 1 day

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

  2. Target Lesion Patency

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Scitech Produtos Medicos SA

Industry

Registry information

Official study title

Solaris Endoprosthesis Performance in Treatment of Patients With Peripheral Occlusive Arterial Disease in the Iliac Territory - Post-Marketing Solaris I Study.

Acronym: SOLARIS I

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 31, 2018
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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