TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry

Completed

• Conditions: Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic
• Interventions: Device: Steerable introducers

• Registration Number: NCT04930172
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-11
• Study First Posted: 2021-06-18
• Study Start: 2022-10-30
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Steerable introducers	Steerable introducers	-

Primary Outcome Measures

Name	Time	Method
technical success	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	30 days	freedom from any branch related complications and/or required reinterventions
clinical success	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

Trial Locations

Locations (7)

Ospedale San Camillo-Forlanini; 🇮🇹 Roma, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Lombardia, Italy

Policlinico S. Orsola Malpighi; 🇮🇹 Bologna, Italy

Azienda Universitaria Giuliano Isontina; 🇮🇹 Cattinara, Italy

Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Azienda Ospedaliera di Perugia; 🇮🇹 Perugia, Italy

Ospedale San Giovanni Addolorata; 🇮🇹 Roma, Italy