SOLARIS Endoprosthesis in Iliac Occlusive Disease (SOLARIS I)

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Endoprosthesis implantation

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Passo Fundo, RS, Brazil
      • Hospital de Clínicas de Passo Fundo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoprosthesis implantation; Device implantation	Device: Endoprosthesis implantation; Endoprosthesis implantation by Percutaneous Angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events	MAE is defined as death related to study device/ procedure, Myocardial Infarction, Target Vessel Revascularization or member amputation	1 day
Target Lesion Patency	Stenosis < 50% and systolic velocity up to 2.5 cm2/s and no TLR	6 months

Collaborators and Investigators

• Sponsor: Scitech Produtos Medicos Ltda
• Investigators: Principal Investigator: Luiz Furuya, MD, Santa Casa de Misericórdia de Santo Amaro

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: SC-SO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No