Clinical trial NCT02433054: Bern Venous Stent Registry
Official title: Bern Venous Stent Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-thrombotic Syndrome
Keywords: deep vein thrombosis
chronic venous disease
May-Thurner syndrome
venous stent
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptoms of chronic venous disease and obstruction and/or stenosis of the iliofemoral veins and/or inferior vena cava.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary patency rate
timeFrame: after one year up to a follow-up of five years
Secondary outcomes:
measure: Primary assisted patency rate
timeFrame: after one year up to a follow-up of five years
measure: Target vessel revascularization
timeFrame: after one year up to a follow-up of five years
measure: Secondary patency rate
timeFrame: after one year up to a follow-up of five years
measure: Revised Venous Clinical Severity Score
timeFrame: after one year up to a follow-up of five years
measure: CEAP-Score
timeFrame: after one year up to a follow-up of five years
measure: 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
timeFrame: after one year up to a follow-up of five years
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Klinik für Angiologie, Universitätsspital Zürich
Study officials:
affiliation: University Hospital Zurich, Clinic of Angiology
name: Nils Kucher, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sebastian 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.
citation: Sebastian 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.
citation: Sebastian 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.
citation: Sebastian 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.
citation: Sebastian 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.