TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry

The purpose of the registry is to evaluate the peri-operative, short-, and mid- outcomes of endovascular treatment of thoracoabdominal aneurysms with multibranched endografts via total transfemoral approach for visceral vessels cannulation using steerable sheaths

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Key information

Conditions

Aortic Aneurysm, Abdominal Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele, Milan, Lombardy, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patient adult ( ≥18 years) of either sex,
patients who underwent a complex aortic procedure requiring a branched endograft via total transfemoral approach in the centers involved in the TORCH2 Registry

Exclusion criteria

patients who did not receive treatment via total transfemoral approach,
patient with bleeding diathesis or coagulopathy,
patients with active systemic or cutaneous infection or inflammation,
patients who are pregnant or lactating,
patient younger than 18 years of age.
Absence of at least one imaging follow-up within the first post-operative year

Treatment and study plan

Steerable introducers

Device

endografts via total transfemoral approach for visceral vessels cannulation

Primary outcomes

technical success

Time frame: 30 days

successful bridging stent graft deployment of all vessels, with aneurysm exclusion, without any signs of type I or type III endoleak, and with no evidence of stenosis/occlusion and mating stent dislocation/kinking at intraoperative completion angiography.
branch instability

Time frame: 30 days

freedom from any branch related complications and/or required reinterventions
clinical success

Time frame: 30 days

absence of death, type I/III endoleak, graft infection/thrombosis, aneurysm expansion and/or rupture, conversion to open repair, or new treatment-related thoracoabdominal pathologies

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

Azienda Ospedaliero, Universitaria Pisana

Registry information

Official study title

A Physician-initiated, National, Multicentre, Ambispective, Observational Registry of Patients Undergoing Branched Endovascular Aortic Procedures With a Total Transfemoral Approach. (TORCH2 Registry)

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 18, 2021
Registry last updated: Nov 14, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed