Post-thrombotic SyndromeNCT02433054
Bern Venous Stent Registry
An observational study of Post-thrombotic Syndrome, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to examine patency rates of self-expanding nitinol stents for treatment of iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis. Moreover, clinical outcome data of patients treated with these venous stents will be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-thrombotic Syndrome
- What is being tested?
- CE-certified dedicated venous stents
- Type of treatment
- Medical device
- How many people
- 548 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to 11 Oct 2023
- How long will I take part?
- 5 Years
- 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 symptoms of chronic venous disease and obstruction and/or stenosis of the iliofemoral veins and/or inferior vena cava.
Who may be able to join
- Patients receiving self-expanding venous nitinol stents for one of the following indications:
- Residual thrombosis of iliofemoral veins and/or inferior vena cava after thrombus removal (by catheter-directed thrombolysis or pharmacomechanical thrombolysis)
- Post-thrombotic syndrome and chronic obstruction of iliofemoral veins and/or inferior vena cava
- Chronic venous insufficiency and presence of non-thrombotic venous stenosis of iliofemoral veins and/or inferior vena cava
Who cannot join
- No consent
- Inability to provide informed consent
- Allergy to Nitinol
- Pregnancy, breast-feeding or birth-giving during the last 30 days
- Life expectancy <3 months
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Angiologie, Universitätsspital Zürich
Zurich, 8091
About this study
The purpose of this study is to examine patency rates of self-expanding nitinol stents for treatment of iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis. Moreover, clinical outcome data of patients treated with these venous stents will be collected.
Read the detailed description
Background: Obstruction and stenosis of the ilio-femoro-caval veins are difficult to treat by conservative measures only. Despite anticoagulation and consequent use of compression stockings, lower extremity venous hypertension affects patients quality of life and health status by causing venous claudication, swelling, skin changes, and venous ulcers. In the last decades venous stenting has become an accepted treatment for ilio-femoro-caval obstruction. Recently, novel self-expanding nitinol stents have been specifically designed for the venous system to account for the anatomical structure of ilio-femoro-caval veins.
Gap of Knowledge: There are few data on short and long term outcomes of self-expanding Nitinol stent placement in ilio-femoro-caval veins.
Objective: To study patency rates and clinical outcome data of self-expanding Nitinol stents that were specifically designed for iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis.
- Conditions
- Post-thrombotic Syndrome
- Being tested
- CE-certified dedicated venous stents
- Keywords
- deep vein thrombosis, chronic venous disease, May-Thurner syndrome, venous stent
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis, May-Thurner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE-certified dedicated venous stentsDevice
Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.
| Study group | Role | What they receive |
|---|---|---|
| CE-certified dedicated venous stents | Patients receiving self-expanding venous nitinol stents. Receives: Device: CE-certified dedicated venous stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
Measured: after one year up to a follow-up of five years
Secondary outcomes (6)
Primary assisted patency rate
Measured: after one year up to a follow-up of five years
Target vessel revascularization
Measured: after one year up to a follow-up of five years
Secondary patency rate
Measured: after one year up to a follow-up of five years
Revised Venous Clinical Severity Score
Measured: after one year up to a follow-up of five years
CEAP-Score
Measured: after one year up to a follow-up of five years
Adverse events: Stent-related: Rethrombosis (early and late), In-Stent restenosis, Stent compression/fracture Clinical: Postthrombotic syndrome, Bleeding (major, minor), Death (VTE-related, Bleeding-related, other), Recurrent VTE at any site
Measured: after one year up to a follow-up of five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJan 2015
- Primary completion11 Apr 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 548 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nils Kucher, University of Zurich
- Investigators
- Nils Kucher, Prof. Dr. med., Principal investigator, University Hospital Zurich, Clinic of Angiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433054
- Sponsor's protocol ID
- 262/ 2014
- Status last verified
- Oct 2023
- First submitted
- 27 Mar 2015
- Last updated
- 12 Oct 2023
- Results posted
- No
Publications
Sebastian T, Barco S, Kreuzpointner R, Konstantinides S, Kucher N. Reversal of cardiopulmonary exercise intolerance in patients with post-thrombotic obstruction of the inferior vena cava. Thromb Res. 2021 Dec;208:219-225. doi: 10.1016/j.thromres.2021.03.025. Epub 2021 Apr 9.
PubMed 33840477Sebastian T, Gnanapiragasam S, Spirk D, Engelberger RP, Moeri L, Lodigiani C, Kreuzpointner R, Barco S, Kucher N. Self-Expandable Nitinol Stents for the Treatment of Nonmalignant Deep Venous Obstruction. Circ Cardiovasc Interv. 2020 Dec;13(12):e009673. doi: 10.1161/CIRCINTERVENTIONS.120.009673. Epub 2020 Dec 4.
PubMed 33272030Sebastian T, Spirk D, Engelberger RP, Dopheide JF, Baumann FA, Barco S, Spescha R, Leeger C, Kucher N. Incidence of Stent Thrombosis after Endovascular Treatment of Iliofemoral or Caval Veins in Patients with the Postthrombotic Syndrome. Thromb Haemost. 2019 Dec;119(12):2064-2073. doi: 10.1055/s-0039-1697955. Epub 2019 Oct 28.
PubMed 31659739Sebastian T, Engelberger RP, Spirk D, Hakki LO, Baumann FA, Spescha RS, Kucher N. Cessation of anticoagulation therapy following endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis. Vasa. 2019 Jul;48(4):331-339. doi: 10.1024/0301-1526/a000774. Epub 2019 Jan 22.
PubMed 30667348Sebastian T, Hakki LO, Spirk D, Baumann FA, Periard D, Banyai M, Spescha RS, Kucher N, Engelberger RP. Rivaroxaban or vitamin-K antagonists following early endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis. Thromb Res. 2018 Dec;172:86-93. doi: 10.1016/j.thromres.2018.10.027. Epub 2018 Oct 26.
PubMed 30391776Sebastian T, Dopheide JF, Engelberger RP, Spirk D, Kucher N. Outcomes of endovascular reconstruction of the inferior vena cava with self-expanding nitinol stents. J Vasc Surg Venous Lymphat Disord. 2018 May;6(3):312-320. doi: 10.1016/j.jvsv.2017.11.012. Epub 2018 Mar 15.
PubMed 29550177
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bern Venous Stent Registry
- ClinicalTrials.gov ID
- NCT02433054
- Acronym / sponsor ID
- 262/ 2014
- Conditions
- Post-thrombotic Syndrome
- Keywords
- deep vein thrombosis, chronic venous disease, May-Thurner syndrome, venous stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 4 May 2015 (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.
The purpose of this study is to examine patency rates of self-expanding nitinol stents for treatment of iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis. Moreover, clinical outcome data of patients treated with these venous stents will be collected.
Detailed description
Background: Obstruction and stenosis of the ilio-femoro-caval veins are difficult to treat by conservative measures only. Despite anticoagulation and consequent use of compression stockings, lower extremity venous hypertension affects patients quality of life and health status by causing venous claudication, swelling, skin changes, and venous ulcers. In the last decades venous stenting has become an accepted treatment for ilio-femoro-caval obstruction. Recently, novel self-expanding nitinol stents have been specifically designed for the venous system to account for the anatomical structure of ilio-femoro-caval veins.
Gap of Knowledge: There are few data on short and long term outcomes of self-expanding Nitinol stent placement in ilio-femoro-caval veins.
Objective: To study patency rates and clinical outcome data of self-expanding Nitinol stents that were specifically designed for iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CE-certified dedicated venous stents | – | Device: CE-certified dedicated venous stentsPatients receiving self-expanding venous nitinol stents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptoms of chronic venous disease and obstruction and/or stenosis of the iliofemoral veins and/or inferior vena cava.
Key inclusion criteria (4 listed)
- Patients receiving self-expanding venous nitinol stents for one of the following indications:
- Residual thrombosis of iliofemoral veins and/or inferior vena cava after thrombus removal (by catheter-directed thrombolysis or pharmacomechanical thrombolysis)
- Post-thrombotic syndrome and chronic obstruction of iliofemoral veins and/or inferior vena cava
- Chronic venous insufficiency and presence of non-thrombotic venous stenosis of iliofemoral veins and/or inferior vena cava
Key exclusion criteria (5 listed)
- No consent
- Inability to provide informed consent
- Allergy to Nitinol
- Pregnancy, breast-feeding or birth-giving during the last 30 days
- Life expectancy <3 months
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 |
|---|---|---|
| CE-certified dedicated venous stentsImplantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava. | Device | CE-certified dedicated venous stents |
Primary outcome
Primary patency rate
Time frame: after one year up to a follow-up of five years
6 secondary outcomes
Primary assisted patency rate
Time frame: after one year up to a follow-up of five years
Target vessel revascularization
Time frame: after one year up to a follow-up of five years
Secondary patency rate
Time frame: after one year up to a follow-up of five years
Revised Venous Clinical Severity Score
Time frame: after one year up to a follow-up of five years
CEAP-Score
Time frame: after one year up to a follow-up of five years
Adverse events: Stent-related: Rethrombosis (early and late), In-Stent restenosis, Stent compression/fracture Clinical: Postthrombotic syndrome, Bleeding (major, minor), Death (VTE-related, Bleeding-related, other), Recurrent VTE at any site
Time frame: after one year up to a follow-up of five 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 Oct 2023.
- Derived from this study: PubMed 33840477Sebastian T, Barco S, Kreuzpointner R, Konstantinides S, Kucher N. Reversal of cardiopulmonary exercise intolerance in patients with post-thrombotic obstruction of the inferior vena cava. Thromb Res. 2021 Dec;208:219-225. doi: 10.1016/j.thromres.2021.03.025. Epub 2021 Apr 9.
- Derived from this study: PubMed 33272030Sebastian T, Gnanapiragasam S, Spirk D, Engelberger RP, Moeri L, Lodigiani C, Kreuzpointner R, Barco S, Kucher N. Self-Expandable Nitinol Stents for the Treatment of Nonmalignant Deep Venous Obstruction. Circ Cardiovasc Interv. 2020 Dec;13(12):e009673. doi: 10.1161/CIRCINTERVENTIONS.120.009673. Epub 2020 Dec 4.
- Derived from this study: PubMed 31659739Sebastian T, Spirk D, Engelberger RP, Dopheide JF, Baumann FA, Barco S, Spescha R, Leeger C, Kucher N. Incidence of Stent Thrombosis after Endovascular Treatment of Iliofemoral or Caval Veins in Patients with the Postthrombotic Syndrome. Thromb Haemost. 2019 Dec;119(12):2064-2073. doi: 10.1055/s-0039-1697955. Epub 2019 Oct 28.
- Derived from this study: PubMed 30667348Sebastian T, Engelberger RP, Spirk D, Hakki LO, Baumann FA, Spescha RS, Kucher N. Cessation of anticoagulation therapy following endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis. Vasa. 2019 Jul;48(4):331-339. doi: 10.1024/0301-1526/a000774. Epub 2019 Jan 22.
- Derived from this study: PubMed 30391776Sebastian T, Hakki LO, Spirk D, Baumann FA, Periard D, Banyai M, Spescha RS, Kucher N, Engelberger RP. Rivaroxaban or vitamin-K antagonists following early endovascular thrombus removal and stent placement for acute iliofemoral deep vein thrombosis. Thromb Res. 2018 Dec;172:86-93. doi: 10.1016/j.thromres.2018.10.027. Epub 2018 Oct 26.
- Derived from this study: PubMed 29550177Sebastian T, Dopheide JF, Engelberger RP, Spirk D, Kucher N. Outcomes of endovascular reconstruction of the inferior vena cava with self-expanding nitinol stents. J Vasc Surg Venous Lymphat Disord. 2018 May;6(3):312-320. doi: 10.1016/j.jvsv.2017.11.012. Epub 2018 Mar 15.
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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
University Hospital Zurich, Clinic of Angiology
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 Post-thrombotic Syndrome, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 5 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 Oct 2023. 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 Switzerland. 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 one year up to a follow-up of five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02433054, which also lists 6 linked publications.
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 Oct 2023.