SOLARIS Endoprosthesis in Iliac Occlusive Disease

Peripheral Arterial Disease Clinical Trial

— SOLARIS I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606629
• Other study ID #: SC-SO-001
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Scitech Produtos Medicos Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Endoprosthesis implantation
Endoprosthesis implantation by Percutaneous Angioplasty

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Passo Fundo	Passo Fundo	RS

Sponsors (1)

Lead Sponsor	Collaborator
Scitech Produtos Medicos Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

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