Completed

NCT Number: NCT06680999

Title Endovascular Treatment of Superior Cave Syndromes Reaching the Trifurcation: a Single-Center Case Series

Superior vena cava syndrome (SCS) is caused by obstruction of blood flow in the superior vena cava, which allows venous return from the upper half of the body to the heart.

The causes are most often oncological, but can also be benign (coagulopathy, Behçet) or iatrogenic (catheterisation, PAC).

The surgical management of superior vena cava syndromes (SCS) involves the use of innovative endovascular techniques, which have become the therapy of first choice for symptomatic patients, whether the occlusion occurs in a benign or malignant context. For occlusive lesions involving the trifurcation, there are several surgical approaches and strategies, but very little data on their efficacy. In particular, Y-stenting has been described in several case reports as a means of treating the SCS and keeping the two jugulo-subclavian veins (VJSC) patent. This innovative technique has been used for several years by the vascular surgery team at Hôpital Louis Pradel.

The aim of our study is to assess the feasibility and medium-term efficacy of innovative endovascular treatments for SCS involving the trifurcation.

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Key information

Conditions

Superior Cave Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vascular and Endovascular Surgery Department, Hôpital Louis Pradel, Hospices Civils de Lyon

Lyon, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients treated by endovascular surgery (stenting) at Hospices Civils de Lyon between March 2019 and July 2023 for superior cave syndrome

Exclusion criteria

Minor patients
Patients unable to give consent
Patients unable to understand French
Patients with lesions not reaching the trifurcation (elective involvement of the superior vena cava)

Treatment and study plan

Data Collection

Other

Preoperative, intraoperative and follow-up data collection: consultation and anesthesia reports, hospitalization reports and imaging data to evaluate the feasibility and efficacy of endovascular treatment of superior vena cava syndromes involving the trifurcation. Data collection will last 1 month and will be performed by a Vascular Surgery resident of the hospital.

Primary outcomes

Technical success, immediate clinical success

Time frame: The primary endpoint will be evaluated by : - Technical success defined by patency postoperatively and at 1 month follow-up confirmed by phleboscanner. Assessment of patency after revascularisation will be based on CT scan data (if possible) or on the r
The primary endpoint will be evaluated by :
- Technical success defined by patency postoperatively and at 1 month follow-up confirmed by phleboscanner.
Assessment of patency after revascularisation will be based on CT scan data (if possible) or on the results of ultrasound data (letter from the angiologist) if this is the only test performed. Re-thrombosis of the inferior vena cava (IVC) or one of the two subclavian jugular veins (SCJV) will be sufficient to establish the absence of patency in our study.
- Immediate clinical success defined by an improvement in symptoms observed by the medical team, and by a Yu score of less than or equal to 1 postoperatively and at 1 month follow-up.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: TESC-Tri

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Nov 8, 2024
Registry last updated: Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.