Bern Venous Stent Registry

NCT02433054 | Completed

• 1 other identifier: 262/ 2014
• Study Type: observational
• Target: 548
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-thrombotic Syndrome

Keywords

deep vein thrombosis; chronic venous disease; May-Thurner syndrome; venous stent

Outcome Measures

Primary Outcomes (1)

• Primary patency rate

  after one year up to a follow-up of five years

Secondary Outcomes (6)

• 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

• 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

Study Arms (1)

CE-certified dedicated venous stents

Patients receiving self-expanding venous nitinol stents.

Device: CE-certified dedicated venous stents

Interventions

CE-certified dedicated venous stents DEVICE

Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.

CE-certified dedicated venous stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Klinik für Angiologie, Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 33840477 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.

  PMID: 33272030 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.

  PMID: 31659739 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.

  PMID: 30667348 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.

  PMID: 30391776 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.

  PMID: 29550177 DERIVED

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis; May-Thurner Syndrome

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Vascular Malformations; Cardiovascular Abnormalities; Peripheral Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nils Kucher, Prof. Dr. med.

  University Hospital Zurich, Clinic of Angiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: May 4, 2015
• Study Start: January 1, 2015
• Primary Completion: April 11, 2023
• Study Completion: October 11, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

CH (1)