TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930172
• Other study ID #: TORCH2
• Status: Completed
• Start date: October 30, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: November 2022
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic

Intervention

Device:
• Steerable introducers
endografts via total transfemoral approach for visceral vessels cannulation

Locations

Country	Name	City	State
Italy	Policlinico S. Orsola Malpighi	Bologna
Italy	Azienda Universitaria Giuliano Isontina	Cattinara
Italy	Ospedale Policlinico San Martino	Genova
Italy	IRCCS Ospedale San Raffaele	Milano	Lombardia
Italy	Azienda Ospedaliera di Perugia	Perugia
Italy	Ospedale San Camillo-Forlanini	Roma
Italy	Ospedale San Giovanni Addolorata	Roma

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Mirza AK, Tenorio ER, Kärkkäinen JM, Hofer J, Macedo T, Cha S, Ozbek P, Oderich GS. Learning curve of fenestrated and branched endovascular aortic repair for pararenal and thoracoabdominal aneurysms. J Vasc Surg. 2020 Aug;72(2):423-434.e1. doi: 10.1016/j.jvs.2019.09.046. Epub 2020 Feb 17. — View Citation

Motta F, Parodi FE, Knowles M, Crowner JR, Pascarella L, McGinigle KL, Marston WA, Kibbe MR, Ohana E, Farber MA. Performance of Viabahn balloon-expandable stent compared with self-expandable covered stents for branched endovascular aortic repair. J Vasc Surg. 2021 Feb;73(2):410-416.e2. doi: 10.1016/j.jvs.2020.05.028. Epub 2020 May 27. — View Citation

Oikonomou K, Kopp R, Katsargyris A, Pfister K, Verhoeven EL, Kasprzak P. Outcomes of fenestrated/branched endografting in post-dissection thoracoabdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):641-8. doi: 10.1016/j.ejvs.2014.07.005. Epub 2014 Aug 28. — View Citation

Tenorio ER, Oderich GS, Farber MA, Schneider DB, Timaran CH, Schanzer A, Beck AW, Motta F, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium Investigators. Outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts. J Vasc Surg. 2020 Sep;72(3):822-836.e9. doi: 10.1016/j.jvs.2019.10.091. Epub 2019 Dec 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	technical success	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.	30 days
Primary	branch instability	freedom from any branch related complications and/or required reinterventions	30 days
Primary	clinical success	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	30 days