Peripheral Arterial DiseaseSOLARIS INCT03606629
SOLARIS Endoprosthesis in Iliac Occlusive Disease
An observational study of Peripheral Arterial Disease, run by Scitech Produtos Medicos SA at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Endoprosthesis implantation
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2019to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Passo Fundo
Passo Fundo, Rio Grande do Sul
About this study
Official title: 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Endoprosthesis implantation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoprosthesis implantationDevice
Endoprosthesis implantation by Percutaneous Angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Endoprosthesis implantation | Device implantation Receives: Device: Endoprosthesis implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events
MAE is defined as death related to study device/ procedure, Myocardial Infarction, Target Vessel Revascularization or member amputation
Measured: 1 day
Target Lesion Patency
Stenosis < 50% and systolic velocity up to 2.5 cm2/s and no TLR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Mar 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luiz Furuya, MD, Principal investigator, Santa Casa de Misericórdia de Santo Amaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606629
- Sponsor's protocol ID
- SC-SO-001
- Acronym
- SOLARIS I
- Status last verified
- May 2022
- First submitted
- 20 Jul 2018
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solaris Endoprosthesis Performance in Treatment of Patients With Peripheral Occlusive Arterial Disease in the Iliac Territory - Post-Marketing Solaris I Study.
- ClinicalTrials.gov ID
- NCT03606629
- Acronym / sponsor ID
- SOLARIS I / SC-SO-001
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoprosthesis implantation | – | Device: Endoprosthesis implantationDevice implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoprosthesis implantationEndoprosthesis implantation by Percutaneous Angioplasty | Device | Endoprosthesis implantation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz Furuya, MD principal investigator
Santa Casa de Misericórdia de Santo Amaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Scitech Produtos Medicos SA at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.