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.
1 other identifier
observational
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedMay 10, 2022
May 1, 2022
2.2 years
July 20, 2018
May 7, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Endoprosthesis implantation
Device implantation
Interventions
Endoprosthesis implantation by Percutaneous Angioplasty
Eligibility Criteria
Patients with POAD presenting limitant intermitent claudication after 6 months of clinical treatment and patients with rest ischemia, Rutherford class 2 to 5.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luiz Furuya, MD
Santa Casa de Misericórdia de Santo Amaro
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2018
First Posted
July 31, 2018
Study Start
March 1, 2019
Primary Completion
April 30, 2021
Study Completion
April 30, 2022
Last Updated
May 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share