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SOLARIS Endoprosthesis in Iliac Occlusive Disease (SOLARIS I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606629
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda

Study Description
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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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Device: Endoprosthesis implantation

Study Design
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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Solaris Endoprosthesis Performance in Treatment of Patients With Peripheral Occlusive Arterial Disease in the Iliac Territory - Post-Marketing Solaris I Study.
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : April 30, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Endoprosthesis implantation
Device implantation
 Device: Endoprosthesis implantation
Endoprosthesis implantation by Percutaneous Angioplasty


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with POAD presenting limitant intermitent claudication after 6 months of clinical treatment and patients with rest ischemia, Rutherford class 2 to 5.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606629


Locations
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Brazil
Hospital de Clínicas de Passo Fundo
Passo Fundo, RS, Brazil
Sponsors and Collaborators
Scitech Produtos Medicos Ltda
Investigators
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Principal Investigator: Luiz Furuya, MD Santa Casa de Misericórdia de Santo Amaro
More Information
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Responsible Party: Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier: NCT03606629    
Other Study ID Numbers: SC-SO-001
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases