ClinicalTrials.gg
CompletedNCT03606629SOLARIS IUpdated May 10, 2022

SOLARIS Endoprosthesis in Iliac Occlusive Disease

An observational study in Peripheral Arterial Disease, sponsored by Scitech Produtos Medicos Ltda. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-10.

Sponsored by Scitech Produtos Medicos Ltda · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 35 studies in Peripheral Arterial Disease with a site in Brazil — 7 open to participants now, 10 under way, 4 of them phase 3. Peripheral Arterial Disease · Brazil.

Started
2019
with 1 other
Observational
8 of 35
none open now
Registered
15th of 35
by date

Among the 35 studies in Peripheral Arterial Disease with a site in Brazil, this one is one of 2 that started in 2019, is one of 8 observational ones, and was the 15th registered.

Peripheral Arterial Disease

1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.

Browse Peripheral Arterial Disease studies →

Open to participants now

7 of the 35 studies in Peripheral Arterial Disease with a site in Brazil are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 192 Peripheral Arterial Disease studies recruiting now, 138 (72%) set no upper age limit and 9 (5%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 35 studies in Peripheral Arterial Disease with a site in Brazil, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Peripheral Arterial Disease
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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;
  • provided.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No

Groups and cohorts

  • Endoprosthesis implantation

    Device implantation

    Device: Endoprosthesis implantation

Interventions

  • DeviceEndoprosthesis implantation

    Endoprosthesis implantation by Percutaneous Angioplasty

06

What researchers measure

Primary outcomes

  1. Major Adverse Events

    MAE is defined as death related to study device/ procedure, Myocardial Infarction, Target Vessel Revascularization or member amputation

    Time frame: 1 day

  2. Target Lesion Patency

    Stenosis \< 50% and systolic velocity up to 2.5 cm2/s and no TLR

    Time frame: 6 months

07

Study locations

1 site
  • Hospital de Clínicas de Passo Fundo
    Passo Fundo, RS, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2019 to primary completion in Apr 2021, 25 months.

Of 58 industry-sponsored observational studies under Peripheral Arterial Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's 25 months is below that.

Counting every sponsor, half of 196 studies reached it within 36 months; a quarter within 22 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2018
First posted
Jul 31, 2018
StartActual
Mar 1, 2019
Primary completionActual
Apr 30, 2021
CompletionActual
Apr 30, 2022
Last update
May 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03606629
Lead sponsor
Scitech Produtos Medicos Ltda
Responsible party
Sponsor
First posted
Jul 31, 2018
Start date
Mar 1, 2019
Primary completion
Apr 30, 2021
Completion
Apr 30, 2022
Last update
May 10, 2022

Study contacts

Luiz Furuya, MD
principal investigator · Santa Casa de Misericórdia de Santo Amaro

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion