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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606629
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda

Tracking Information
First Submitted Date July 20, 2018
First Posted Date July 31, 2018
Last Update Posted Date September 4, 2020
Actual Study Start Date March 1, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2019)
  • 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
  • Target Lesion Patency [ Time Frame: 6 months ]
    Stenosis < 50% and systolic velocity up to 2.5 cm2/s and no TLR
Original Primary Outcome Measures
 (submitted: July 20, 2018)
  • Major Adverse Events rates [ Time Frame: 12 months ]
    MAE rates defined as death related to study device/ procedure, Myocardial Infarction, Target Vessel Revascularization or member amputation
  • Vessel Patency [ Time Frame: 12 months ]
    Vessel patency (primary, assisted and secondary)
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SOLARIS Endoprosthesis in Iliac Occlusive Disease
Official Title Solaris Endoprosthesis Performance in Treatment of Patients With Peripheral Occlusive Arterial Disease in the Iliac Territory - Post-Marketing Solaris I Study.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Peripheral Arterial Disease
Intervention Device: Endoprosthesis implantation
Endoprosthesis implantation by Percutaneous Angioplasty
Study Groups/Cohorts Endoprosthesis implantation
Device implantation
Intervention: Device: Endoprosthesis implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 20, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2023
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Juliana Castro, PhD +55 11 21258900 jcastro@scitechmed.com
Contact: Juliana Castro +55 11 21258900 jcastro@scitechmed.com
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03606629
Other Study ID Numbers SC-SO-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Scitech Produtos Medicos Ltda
Study Sponsor Scitech Produtos Medicos Ltda
Collaborators Not Provided
Investigators
Principal Investigator: Luiz Furuya, MD Santa Casa de Misericórdia de Santo Amaro
PRS Account Scitech Produtos Medicos Ltda
Verification Date September 2020