Post-thrombotic SyndromeNCT02942394
Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study
An observational study of Post-thrombotic Syndrome and Iliac Vein Compression Syndrome, run by Optimed Medizinische Instrumente GmbH at 7 sites in 4 countries.
Trial summary
Primary objective: To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by evaluating different gradations of patency rates, patient's rating of disease severity and quality of life in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-thrombotic Syndrome, Iliac Vein Compression Syndrome
- What is being tested?
- sinus-Obliquus Stent System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Dec 2016to 17 Dec 2020
- 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 post-thrombotic syndrome and concomitant common iliac vein compression.
Who may be able to join
- Male or female adults aged ≥18 years
- Post-thrombotic syndrome (Villalta score >4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis
- Evidence of venous stenosis in common iliac vein >50% confirmed by venography (CT or MRI) or intravascular ultrasound (IVUS)
- Use of sinus-Obliquus stent for unilateral common iliac vein stenosis
- If stent extension is required either sinus-XL Flex or sinus-Venous stents must have been used for stenoses >50% confirmed by venography (CT or MRI) or IVUS in external iliac and common femoral veins
Who cannot join
- Pregnancy, breast-feeding or birth-giving during the last 30 days
- Life expectancy <6 months
- Iliofemoral DVT less than 3 months ago
- Permanently immobile patient (wheelchair user or bed-ridden patient)
- Allergy to Nitinol
- Patient's target vessel(s) has/have been stented before
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
- Patients in custody by juridical or official order
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Germany3 sites
Karolinen Hospital Arnsberg
Arnsberg, 59759
Medizinische Universitätsklinik Heidelberg
Heidelberg, 69120
Universität des Saarlandes
Homburg, 66424
Switzerland2 sites
INSELSPITAL, Universitätsspital Bern
Bern, 3010
Universitätsspital Zürich
Zurich, 8091
About this study
Official title: Non-interventional, Multicenter, Multinational Venous Stent Study for the Treatment of the Post-thrombotic Syndrome With Common Iliac Vein Compression
Primary objective:
To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by evaluating different gradations of patency rates, patient's rating of disease severity and quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein compression.
Secondary objective:
To assess long-term safety of venous stenting
- Being tested
- sinus-Obliquus Stent System
- Medical subject headings
- Postthrombotic Syndrome, May-Thurner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus-Obliquus Stent SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency Rate
Measured: After 3 months up to a follow-up of 2 years.
Secondary outcomes (2)
Primary Assisted Patency Rate
Measured: After 3 months up to a follow-up of 2 years.
Secondary Patency Rate
Measured: After 3 months up to a follow-up of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-thrombotic SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimed Medizinische Instrumente GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nils Kucher, Prof. Dr. med., Principal investigator, Director Clinic for Angiology Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942394
- Sponsor's protocol ID
- SONIS15473
- Status last verified
- Jan 2021
- First submitted
- 19 Oct 2016
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Multicenter, Multinational Venous Stent Study for the Treatment of the Post-thrombotic Syndrome With Common Iliac Vein Compression
- ClinicalTrials.gov ID
- NCT02942394
- Acronym / sponsor ID
- SONIS15473
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Optimed Medizinische Instrumente GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 24 Oct 2016 (estimated)
- 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.
Primary objective:
To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by evaluating different gradations of patency rates, patient's rating of disease severity and quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein compression.
Secondary objective:
To assess long-term safety of venous stenting
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with post-thrombotic syndrome and concomitant common iliac vein compression.
Key inclusion criteria (5 listed)
- Male or female adults aged ≥18 years
- Post-thrombotic syndrome (Villalta score >4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis
- Evidence of venous stenosis in common iliac vein >50% confirmed by venography (CT or MRI) or intravascular ultrasound (IVUS)
- Use of sinus-Obliquus stent for unilateral common iliac vein stenosis
- If stent extension is required either sinus-XL Flex or sinus-Venous stents must have been used for stenoses >50% confirmed by venography (CT or MRI) or IVUS in external iliac and common femoral veins
Key exclusion criteria (8 listed)
- Pregnancy, breast-feeding or birth-giving during the last 30 days
- Life expectancy <6 months
- Iliofemoral DVT less than 3 months ago
- Permanently immobile patient (wheelchair user or bed-ridden patient)
- Allergy to Nitinol
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 |
|---|---|---|
| sinus-Obliquus Stent System | Device | – |
Primary outcome
Primary Patency Rate
Time frame: After 3 months up to a follow-up of 2 years.
2 secondary outcomes
Primary Assisted Patency Rate
Time frame: After 3 months up to a follow-up of 2 years.
Secondary Patency Rate
Time frame: After 3 months up to a follow-up of 2 years.
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 12 Jan 2021.
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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.
Nils Kucher, Prof. Dr. med. principal investigator
Director Clinic for Angiology Universitätsspital Zürich
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-thrombotic Syndrome and Iliac Vein Compression Syndrome, run by Optimed Medizinische Instrumente GmbH at 7 sites in 4 countries.
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 5 inclusion and 8 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Switzerland, Austria, Netherlands. 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?
Primary Patency Rate (time frame: After 3 months up to a follow-up of 2 years.). 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 12 Jan 2021.