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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CE-certified dedicated venous stents | Patients receiving self-expanding venous nitinol stents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE-certified dedicated venous stents | Device | Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency rate | after one year up to a follow-up of five years |
| Measure | Description | Time Frame |
|---|---|---|
| Primary assisted patency rate | after one year up to a follow-up of five years | |
| Target vessel revascularization | after one year up to a follow-up of five years | |
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Inclusion Criteria:
Patients receiving self-expanding venous nitinol stents for one of the following indications:
Exclusion Criteria:
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Patients with symptoms of chronic venous disease and obstruction and/or stenosis of the iliofemoral veins and/or inferior vena cava.
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| Name | Affiliation | Role |
|---|---|---|
| Nils Kucher, Prof. Dr. med. | University Hospital Zurich, Clinic of Angiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Angiologie, Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33840477 | Derived | 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. | |
| 33272030 | Derived | 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. |
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| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| D020246 | Venous Thrombosis |
| D062108 | May-Thurner Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Secondary patency rate |
| after one year up to a follow-up of five years |
| Revised Venous Clinical Severity Score | after one year up to a follow-up of five years |
| CEAP-Score | 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 | after one year up to a follow-up of five years |
| 31659739 | Derived | 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. |
| 30667348 | Derived | 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. |
| 30391776 | Derived | 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. |
| 29550177 | Derived | 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. |
| D014689 |
| Venous Insufficiency |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D016491 | Peripheral Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |